Category Archives: Pharmaceutical and Cosmetic Products

The European pharmaceutical industry has an important role to play in ensuring that the people of Europe enjoy a good standard of health. The European Union strives, therefore, to guarantee broad access to medicinal products, to provide the public with high quality information, and to ensure that the medicinal products manufactured are safe and effective. The single market for pharmaceutical products makes it possible to achieve these aims by increasing the competitiveness of the industry through promoting research and innovation for the benefit of the public.
The European cosmetic industry is an important employer. 150 000 people work in the industry itself, and the sale, distribution and transport of cosmetics indirectly creates a further 350 000 jobs. With a production value of more than €35 billion, this innovative industry is a world leader in the field. The European Union aims to ensure free movement of cosmetic products in the internal market and to guarantee that the products are safe.

Internal Market

Internal Market

Internal Market Contents

  • Internal market: general framework
  • Living and working in the internal market: Free movement of people, asylum and immigration, free movement of workers
  • Single Market for Goods: Free movement of goods, technical harmonisation, product labelling and packaging, consumer safety, pharmaceutical and cosmetic products, chemical products, motor vehicles, construction, external dimension
  • Single market for services: Free movement of services, professional occupations, services of general interest, transport, Information Society, postal services, financial services, banks, insurance, securities markets
  • Single market for capital: Free movement of capital, economic and monetary union, economic and private stakeholders, fiscal aspects, combating fraud, external relations
  • Businesses in the internal market: Company law, public procurement, intellectual property

See also

Living and working in the internal market.
Overviews of European Union: Internal market.
Further information: the Internal Market and Services Directorate-General of the European Commission.

Medicinal products for paediatric use

Medicinal products for paediatric use

Outline of the Community (European Union) legislation about Medicinal products for paediatric use

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Medicinal products for paediatric use

Document or Iniciative

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001/20/EC and 2001/83/EC, and Regulation (EC) No 726/2004 . [See amending acts].

Summary

This European Union (EU) Regulation aims to improve the health and quality of life of children in Europe by ensuring that new medicines for children and medicines already on the market are fully adapted to their specific needs. In order to fill the gaps in research on this type of medicinal product, the Regulation lays down new obligations for the pharmaceutical industry accompanied by rewards and incentives. The Regulation therefore also contributes to the competitiveness of the European pharmaceutical industry.

The aims to be achieved are as follows:

  • to stimulate the development of medicines for use in children;
  • to ensure that medicines used to treat children are subject to high-quality, ethical research;
  • to ensure that these medicines are appropriately authorised for use in children;
  • to improve the information available on the use of medicines in children;
  • to achieve these objectives without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicines for other categories of patient.

The Community instruments already in force in the pharmaceutical sector will have a key role to play in achieving these aims. Moreover, as regards the procedure for placing pharmaceutical products on the market, the procedures established by current pharmaceutical legislation have not been altered. However, for every marketing authorisation application, the competent authorities will check compliance with the agreed paediatric investigation plan * or verify the presence of a waiver or deferral.

Paediatric Committee

The Regulation’s key feature is the establishment of a Paediatric Committee within the European Medicines Agency (EMEA) *. This committee is made up of five members of the Committee on Medicinal Products for Human Use and their alternates, a member and an alternate appointed by each of the Member States not represented by members of the Committee on Medicinal Products for Human Use, three members and three alternates selected by the Commission to represent the health professions, and three members and their alternates appointed by the Commission to represent patients’ associations.

The committee is specifically responsible for advising on questions concerning medicinal products for paediatric use, issuing opinions on the quality, safety and efficacy of medicinal products for paediatric use, assessing and approving companies’ paediatric investigation plans * and considering any related requests for waivers and deferrals. The paediatric investigation plan is the document upon which the development and authorisation of medicines for use in children must be based. It should include details of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the medicinal product in a paediatric population. *

In the course of its work, the Paediatric Committee will consider the therapeutic benefits of carrying out studies in children and ensure that unnecessary studies are avoided. It must also ensure that authorisations for medicines for other populations are not delayed by the requirements for studies in children.

Given that certain medicines developed for adults are not suitable for children, the Paediatric Committee will draw up lists of waivers for specific medicines and classes of medicine.

Marketing authorisation procedures and rewards

This Regulation concerns medicines under development which have yet to be authorised, authorised products covered by a supplementary protection certificate or a patent, and authorised products no longer covered by either a supplementary protection certificate or a patent.

A request for marketing authorisation for paediatric * use does not affect the right to apply for authorisation to market the product for other uses.

When all the measures in the paediatric investigation plan * have been complied with, this fact will be recorded in the marketing authorisation. Implementation of these measures will be the basis upon which companies can obtain the rewards for compliance. The provisions differ according to the category of medicine in question, namely:

  • medicinal products no longer covered by a patent: a medicinal product which is no longer covered by a patent may be subject to a new marketing authorisation for paediatric use. It may enjoy a new period of market exclusivity of 10 years. This type of authorisation is called Paediatric Use Marketing Authorisation (PUMA). A medicinal product that has obtained a PUMA can use the existing brand name of the corresponding authorised product in order to take advantage of the latter product’s reputation.
  • new medicines and products covered by a patent or a(SPC): if all the measures included in the agreed paediatric investigation plan * are complied with, if the product is authorised in all Member States and if relevant information on the results of studies is included in product information, a six-month SPC extension will be granted.
  • orphan medicinal products*: this category of medicinal products qualifies for ten years of market exclusivity. This period will be extended to twelve years if the requirements for data on use in children are fully met.

European network

The Paediatric Committee must help the EMEA to establish a European network linking together existing national and European networks, researchers and study centres. This network will facilitate cooperation and avoid duplication of studies on the paediatric population.

Information on medicines for children

Increased availability of information facilitates the safe and effective use of medicines for children. Companies are therefore invited to submit all completed studies to the competent authorities. The European database contains information on clinical paediatric studies, whether completed or ongoing, in the Community and non-member countries. By way of derogation the EMEA will reveal to the public some of the information on clinical paediatric studies contained in the European database.

Details of the results of paediatric studies, the status of paediatric investigation plans, and any waivers or deferrals must be included in the product information in order to inform healthcare professionals and patients about the safe and effective use of children’s medicines.

Context

This Regulation follows on from a proposal for a European Parliament and Council Regulation of 29 September 2004, which in turn was a response to Council Resolution of 14 December 2000 inviting the Commission to propose measures to address the lack of medicines specifically designed for the paediatric population *. Children today remain exposed to diseases without benefiting from the same technological advances as adults. Market forces have not sufficiently stimulated the development of medicines specifically designed for children, since companies have insufficient income to finance the necessary research. Moreover, attempts to solve the problem at national level have proved ineffective. It is for these reasons that action at Community level has been deemed necessary.

Key terms used in the act
  • Paediatric population: that part of the population aged between 0 and 18 years.
  • European Medicines Agency: created in London on 26 January 1995, it contributes to consumer protection and the establishment of a single market for human and veterinary medicinal products by standardising the sale of certain medicines and improving supervision of their use.
  • Paediatric investigation plan: a research and development programme aimed at ensuring that the necessary data are generated to determine the conditions under which a medicinal product may be authorised to treat the paediatric population.
  • Marketing authorisation for paediatric use: authorisation granted for a medicine for human use that is not protected by a supplementary protection certificate or a patent, covering therapeutic indications for use on the paediatric population, including the dosage, pharmaceutical form or route of administration of the product in question.
  • Orphan medicines: medicines for the treatment of diseases so rare that promoters are reluctant to develop them under normal market conditions. These medicines are designed for the treatment of patients with very serious and even fatal diseases for which there is not yet any treatment, or at least any satisfactory treatment. Many of these diseases affect children and newly-born babies.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1901/2006 26.1.2007 OJ L 378 of 27.12.2006
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1902/2006 26.1.2007 OJ L 378 of 27.12.2006

Related Acts

Regulation (EC) No 726/2004of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Official Journal L136 of 30.4.2004].

Directive 2001/83/ECof the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Official Journal L 311 of 28.11.2001].

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [Official Journal L 121 of 1.5.2001].

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products [Official Journal L 182 of 2.7.1992].

Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Outline of the Community (European Union) legislation about Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Document or Iniciative

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

Summary

Commission Directive 91/356/EEC laid down the principles and guidelines of good manufacturing practice* only for medicinal products* for human use. The majority of the provisions in Directive 91/356/EEC therefore had to be amended, extended and adapted in order to cover good manufacturing practice for investigational* medicinal products for human use. This Directive therefore repeals Directive 91/356/EEC in order to lay down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

The principles and guidelines of good manufacturing practice relate mainly to personnel, premises and equipment, production, documentation, quality control and labelling, work contracted out, inspections, complaints and product recalls.

Quality assurance system: personnel, premises and equipment

The manufacturer implements an effective pharmaceutical* quality assurance system, involving the management and personnel of the various departments concerned.

At each manufacturing site, the manufacturer has personnel with the skills to achieve the pharmaceutical quality assurance objective.

The personnel receives regular training covering the theory and application of quality assurance and good manufacturing practice and the requirements for the manufacture of investigational medicinal products.

Hygiene programmes that are adapted to the activities to be carried out must be established. These must include procedures relating to the health, hygiene practice and clothing of personnel.

Premises and manufacturing equipment must also be subject to extremely strict hygiene standards in order to avoid contamination and any adverse effect on the quality of the product.

Moreover, premises and equipment used for manufacturing operations which are critical for the quality of the products must be subjected to appropriate validation.

Production

Production must be carried out in accordance with good manufacturing practice and must follow the pre-established instructions and procedures. Process deviations and product defects must be documented and investigated.

Technical and/or organisational measures must be taken in order to avoid, in particular, cross-contamination. In the case of investigational medicinal products, particular attention must be paid to the handling of products during and after any blinding operation*.

For medicinal products, new manufacturing processes and those that have been substantially changed must be validated, and critical phases of the manufacturing process must be regularly revalidated.

In the case of investigational medicinal products, at least the critical process steps, such as sterilisation, and if necessary the manufacturing process in its entirety must be validated.

Documentation

The manufacturer must set up a system of documentation covering the various manufacturing operations carried out. These documents trace the history of the manufacture of each batch and the changes introduced during the development of an investigational medicinal product.

Electronic or other data processing systems may replace written documents. In this case, the manufacturer must prove that the data will be appropriately stored during the period in question.

Quality control and labelling

The manufacturer must set up a quality control system. This system is placed under the authority of a person who has the requisite qualifications and is independent of production. This person has access to quality control laboratories in order to carry out the necessary examination of the starting materials and packaging materials and the testing of intermediate and finished products. Contract laboratories may be used if authorised.

During the final control of the finished product before its release, the quality control system must take into account the production conditions, the results of in-process controls, the examination of the manufacturing documents and the conformity of the product to its specifications.

Samples of each batch of finished medicinal product must be retained for at least one year after the expiry date. In the case of investigational medicinal products, samples of each batch of bulk formulated product and of key packaging components used for each finished product batch must be retained for at least two years after completion of the last clinical trial in which the batch was used.

In addition, samples of certain raw materials used in the manufacturing process must be retained for at least two years after the release of the product. This period may be shortened in certain cases.

For investigational medicinal products, labelling must be such as to ensure protection of the subject and traceability, facilitate proper use of the investigational medicinal product and allow identification of the product and trial.

Work contracted out

Any manufacturing operation must be the subject of a written contract between the contract giver and the contract acceptor. This contract sets out the responsibilities of each party. The contract acceptor must respect the principles and guidelines of good manufacturing practice and must submit to inspections carried out by the competent authorities.

Complaints, product recall and emergency unblinding*

Member States must set up inspections in order to ensure that manufacturers* respect the principles and guidelines of good manufacturing practice laid down by this Directive. They must also take into account Community procedures on inspections and exchange of information.

The manufacturer must ensure that manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorisation, including medicinal products intended for export. Regular self-inspections must be conducted in order to monitor compliance with good manufacturing practice and, if necessary, to propose corrective measures.

For the purposes of interpreting the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities must refer to the guidelines set out in the “Guide to good manufacturing practice (GMP) for medicinal products and for investigational medicinal products” , published by the Commission.

With regard to medicinal products and investigational medicinal products imported from third countries, importers must ensure that their manufacture conforms to standards equivalent to the good manufacturing practice developed by the Community. Moreover, an importer of medicinal products must ensure that the persons manufacturing these are authorised manufacturers, and an importer of investigational medicinal products must ensure that their manufacturer is notified to the competent authorities and accepted by them.

To place a medicinal product on the market in a Member State, a marketing authorisation must be granted by the competent authority of that Member State or by the European Agency for the Evaluation of Medicinal Products. The manufacturer must ensure that medicinal products are manufactured in accordance with the information provided in the application for marketing authorisation as accepted by the competent authorities.

With regard to investigational medicinal products, the manufacturer must ensure that they are manufactured in accordance with the information provided by the sponsor and accepted by the competent authorities.

For both medicinal products and investigational medicinal products, the manufacturer must examine and record complaints regarding a defect. He must inform the competent authority of any defect that could result in a recall or restriction on supply and indicate the country of destination. In the case of investigational medicinal products, he must also indicate the trial sites.

For investigational medicinal products, the sponsor must implement a procedure for the rapid unblinding of blinded products, where this is necessary for a prompt recall. The sponsor must also ensure that the procedure discloses the identity of the blinded product only in so far as is necessary.

Key terms in the Act
  • Good manufacturing practice: the part of quality assurance which ensures that medicinal products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use.
  • Medicinal product: any product as defined in Article 1(2) of Directive 2001/83/EC.
  • Investigational medicinal product: any product as defined in Article 2(d) of Directive 2001/20/EC.
  • Manufacturer: any person engaged in activities for which the authorisation referred to in Article 40(1) and (3) of Directive 2001/83/EC or the authorisation referred to in Article 13(1) of Directive 2001/20/EC is required.
  • Pharmaceutical quality assurance: the total sum of the organised arrangements made with the object of ensuring that medicinal products or investigational medicinal products are of the quality required for their intended use.
  • Blinding: the deliberate disguising of the identity of an investigational medicinal product in accordance with the instructions of the sponsor.
  • Unblinding: the disclosure of the identity of a blinded product.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2003/94/EC 20 days after publication in the Official Journal (04.11.2003) 30.04.2004 OJ L 262, 14.10.2003

Related Acts

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Official Journal L 136, 30.04.2004].

Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use [Official Journal L 136, 30.04.2004].

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Official Journal L 311, 28.11.2001].

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [Official Journal L 121, 01.05.2001].

Good manufacturing practice for veterinary medicinal products

Good manufacturing practice for veterinary medicinal products

Outline of the Community (European Union) legislation about Good manufacturing practice for veterinary medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Good manufacturing practice for veterinary medicinal products

Document or Iniciative

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

Summary

Veterinary medicinal products manufactured or imported into the Community, including those intended for export, must be manufactured in accordance with the principles and guidelines of good manufacturing practice *.

The principles and guidelines primarily concern personnel, premises and equipment, production, documentation, quality control, contracting out, and inspections, complaints and product recall.

Quality assurance system: personnel, premises and equipment

Manufacturers * must set up an effective pharmaceutical quality assurance system *, involving the management and personnel of the various services concerned.

At each manufacturing site, the manufacturer must have persons responsible for implementing the good manufacturing practice, who have the expertise required to achieve the objective of pharmaceutical quality assurance.

Personnel must receive regular training, covering the theoretical and practical aspects of quality assurance and good manufacturing practice.

Hygiene programmes adapted to the activities must be established, including procedures relating to health, hygiene and clothing of personnel.

Premises and equipment must also be subject to strict hygiene standards in order to prevent contamination and any adverse effect on the quality of products. Moreover, premises and equipment to be used for manufacturing operations which are critical for the quality of the products must be checked for suitability.

Production

Production must be carried out in accordance with good manufacturing practice and must follow the pre-established instructions and procedures.

Technical or organisational measures must be taken in order to avoid, in particular, cross-contamination.

New manufacturing processes and those that have been substantially changed must be validated, while critical phases of the manufacturing process must be regularly revalidated.

Documentation

Manufacturers must use a system of documentation covering the various manufacturing operations performed. These documents trace the history of the manufacture of each batch.

Electronic or other data processing systems may replace written documents. In this case, the manufacturer must prove that the data will be appropriately stored during the period in question.

Quality control

Manufacturers must have a quality control department at their disposal. This department must be placed under the authority of a person independent of the other departments and having the required qualifications. It must have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary testing of the raw materials and packaging materials and the intermediate and finished products. Resorting to outside laboratories may be authorised.

During the final control of finished products before their release for sale or distribution, the quality control department must take into account, in particular, production conditions, results of in-process controls, the examination of the manufacturing documents and the conformity of products with their specifications.

Samples of each batch of finished products must be retained for at least one year after the expiry date. In addition, samples of certain raw materials must be retained for at least two years after the release of the product. This period may be shortened in certain cases.

Work contracted out

Any manufacturing operation must be the subject of a written contract between the contract giver and the contract acceptor. This contract must set out the responsibilities of each party. The contract acceptor must respect the principles and guidelines of good manufacturing practice and must submit to inspections carried out by the competent authorities.

Inspections, complaints and product recall

Member States must set up regular inspections in order to ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive.

Manufacturers must ensure that the manufacture of medicinal products complies with good manufacturing practice and with the manufacturing authorisation. Regular self-inspections must be conducted in order to monitor the respect of good manufacturing practice and, if necessary, to propose corrective measures.

The competent authorities of each Member State must prepare reports on the observance of good manufacturing practices, which must be communicated upon request to the competent authorities of another Member State.

For the interpretation of the principles and guidelines of good manufacturing practice, the manufacturers and the competent authorities must refer to the guidelines set out in the “Good manufacturing practice guidelines” (EN).

With regard to veterinary medicinal products imported from third countries, importers must ensure that their manufacture conforms to standards equivalent to the good manufacturing practice developed by the Community. In addition, they must ensure that the persons manufacturing these are authorised manufacturers.

Manufacturers must set up a system for recording and reviewing complaints together with an effective system for recalling promptly the veterinary medicinal products in the distribution network. They must examine and record complaints regarding a quality defect, and must inform the competent authorities of any quality defect that may result in a recall or abnormal restriction on the supply. They must also indicate the countries of destination.

Key terms in the Act
  • Good manufacturing practice: the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use.
  • Manufacturer: any holder of the authorisation referred to in Article 44 of Directive 2001/82/EEC.
  • Pharmaceutical quality assurance: the sum total of the organised arrangements made in order to ensure that veterinary medicinal products are of the quality required for their intended use.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 91/412/EEC 20 days after publication in the Official Journal 23.07.1993 OJ L 228, 17.08.1991.

Related Acts

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency [Official Journal L136, 30.04.2004].

Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products [Official Journal L 136, 30.04.2004].

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [Official Journal L 311 of 28.11.2001].

A renewed vision for the pharmaceutical sector

A renewed vision for the pharmaceutical sector

Outline of the Community (European Union) legislation about A renewed vision for the pharmaceutical sector

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

A renewed vision for the pharmaceutical sector

Document or Iniciative

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 21 December 2008 – ‘Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector’ [COM(2008) 666 final – Not published in the Official Journal].

Summary

This Communication lays down objectives relating to the future of the pharmaceutical sector.

The new regulatory framework should contribute to reinforcing the safety of pharmaceuticals, encouraging innovation and making medicines more accessible for European patients.

Making progress towards a single market in pharmaceuticals

Better access to medicines

European patients should be able to benefit from scientific progress and obtain the medicines that they need for therapeutic purposes. Two options have been envisaged:

  • to put the emphasis on smaller markets thanks to cooperation with Member States up to 2010;
  • to identify, by 2010, ways to optimise the functioning of the network of European Union medicines authorities.

Transparency and the exchange of information in the field of pricing and reimbursement should be improved.

Better regulation for a more competitive industry

Regulation should be improved, particularly in the field of clinical trials. The first step towards improving regulation should be an assessment of the application of Directive 2001/20/EC on clinical trials by 2010.

Safer medicines for better informed citizens

The safety of medicines should be reinforced by the legislative proposal on pharmacovigilance. In parallel, it is important to provide the patients who request it with reliable and objective information on the medicines to which they have access.

The environment issue also comes into play via the proposing of measures aimed at reducing the negative effects of pharmaceuticals on the environment and public health.

Taking on the opportunities and challenges of globalisation

Tackling worldwide health challenges

To combat the circulation of illegal medicines, it is necessary to reinforce the exchange of information at international level by 2012 and to help third countries to take appropriate measures.

In the area of pandemics, bilateral and multilateral relations should be strengthened.

Global cooperation and harmonisation

Inspection mechanisms with the United States, Japan and Canada should be established by 2010. In addition, bilateral cooperation with Russia, India and China should be extended.

International harmonisation is advocated, particularly by means of the International Conference on Harmonisation (ICH). It is also recommended that the areas of the Transatlantic Economic Council (TEC) be used for the simplification and convergence of rules between the United States and the European Union.

Finally, for the European Union to be internationally competitive, the Communication encourages it to implement and enforce the framework of the World Trade Organisation (WTO), as well as the Free Trade Agreements (FTAs) in particular as regards the protection of intellectual property rights.

Making science deliver for European patients

Supporting pharmaceutical research

The Innovative Medicines Initiative (IMI) is to accelerate medicine development so as to make new treatment options available to patients earlier.

New horizons in medicine

These new horizons include two main challenges:

  • advanced therapies such as regenerative medicine should be reevaluated by 2012;
  • new technologies such as pharmacogenomics which make it possible to offer patients personalised treatment.

Background

At the beginning of the 21st century, Europe is facing challenges such as pharmaceutical innovation, shortcomings in the availability of medicines, the increasing globalisation of the sector and scientific breakthroughs.

It therefore appears important to shape a Community framework which allows continued progress toward a single and sustainable market in pharmaceuticals to be made, advantage to be taken of the opportunities and challenges associated with globalisation, and European patients to benefit from scientific progress.

Supplementary protection certificate for medicinal products

Supplementary protection certificate for medicinal products

Outline of the Community (European Union) legislation about Supplementary protection certificate for medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Supplementary protection certificate for medicinal products

Document or Iniciative

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (Text with EEA relevance).

Summary

The purpose of the supplementary protection certificate for medicinal products is to remedy the disparities and shortcomings in national patenting systems for pharmaceutical research. It aims in particular to guarantee sufficient protection for the development of medicinal products in the European Union (EU).

Indeed, the period between the filing of a patent application for a new medicinal product * and authorisation to place it on the market constitutes one of the factors which actually reduces the effective protection afforded by the patent and can compromise the amortisation of investment in research. The lack of sufficient protection can also lead research centres based in the Member States to relocate to countries offering better protection.

In order to also guarantee the free movement of medicinal products, the supplementary certificate for the protection of medicinal products also aims to prevent the development of too many disparities in national legislation.

The certificate is issued if the product for which it was requested, as a medicinal product and at the time when the application was filed in a Member State, meets the following conditions:

  • the product * is protected by a basic patent * in force;
  • the product, as a medicinal product, has been granted a marketing authorisation;
  • the product has not already been the subject of a certificate;
  • the marketing authorisation is the first authorisation to place the product on the market as a medicinal product.

Furthermore, the certificate applies to the product in the same way as the patent from which it benefits. The Regulation also specifies the arrangements relating to application for and granting of the certificate and likewise the conditions for lapse, invalidity and publicity of the certificate.

The certificate cannot be granted for a period exceeding five years. Furthermore, the duration of protection afforded by a patent and by the certificate cannot exceed 15 years overall for the holder’s first marketing authorisation.

This Regulation codifies and repeals Regulation (EEC) No 1768/92.

Key terms in the Act
  • Medicinal product: any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or animals.
  • Product: the active ingredient or combination of active ingredients of a medicinal product.
  • Basic patent: a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EEC) No 469/2009

6.7.2009

OJ L152 of 16.6.2009

Colouring matters for medicinal products

Colouring matters for medicinal products

Outline of the Community (European Union) legislation about Colouring matters for medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Colouring matters for medicinal products (recast)

Document or Iniciative

Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (recast) (Text with EEA relevance).

Summary

This Directive gives specifications on colouring matters for medicinal products.

Only the colouring matters listed in Annex I to Directive 94/36/EC may be used to colour medicinal products for human and veterinary use.

The colouring matters referred to in Annex I must meet the general specifications for aluminium lakes of colours and the specific criteria of purity laid down in Annex I to Directive 95/45/EC. The methods of analysis needed to verify these criteria are framed by Directive 81/712/EC.

When a colouring matter is deleted from Annex I to Directive 94/36/EC, but the marketing of foodstuffs containing this colouring matter is permitted to continue for a limited period, this additional period of use also extends to medicinal products. However, the Commission may amend the duration of this additional period.

The Commission shall be assisted by a committee for the adjustment to technical progress of the Directives composed of representatives from Member States and chaired by a Commission representative.

This Directive repeals Directive 78/25/EC.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2009/35/EC

20.5.2009

OJ L109 of 30.4.2009

This summary is for information only. It is not designed to interpret or replace the reference document, which remains the only binding legal text.

Good clinical practice

Good clinical practice

Outline of the Community (European Union) legislation about Good clinical practice

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Good clinical practice

Document or Iniciative

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. [See amending acts].

Summary

This Directive concerns clinical trials of medicinal products including multi-centre trials.

This Directive does not apply to non-interventional clinical trials.

Protection of clinical trial subjects

The trial subjects are protected. On the one hand, a clinical trial may only be undertaken if the risks to the subject are not disproportionate to the potential benefits of the medical research. On the other hand, the right of the subject to physical and mental integrity must be respected, as well as the right to privacy.

The medical care given to the subjects and medical decisions made on their behalf are the responsibility of an appropriately qualified physician.

Trial subjects are to be provided with a contact point, where further information can be obtained.

Role of the Ethics Committee

In preparing its opinion on clinical trials, the Ethics Committee must take into consideration a certain number of elements, in particular:

  • the relevance of the trial and the trial design;
  • the protocol;
  • the suitability of the investigator (i.e. the person responsible for performing the clinical trials on a site) and his supporting staff;
  • the quality of the facilities.

The Ethics Committee’s opinion must be delivered before the start of the clinical trials.
Member States must establish a procedure by which a single Ethics Committee opinion must be delivered for each Member State, including the case of multi-centre clinical trials.

Conduct of a clinical trial

The Directive describes the conditions and time limits to be respected in order to begin a clinical trial.

The sponsor (i.e. the person, firm, institution or body responsible for mounting, managing and/or funding the clinical trial) must, within 90 days of completion of the clinical trial, duly inform the Member States.

Member States on whose territory the clinical trial is performed must enter data extracted from the initial request, amendments as appropriate and the notification at the end of the clinical trial, into a database.

The European Medicines Evaluation Agency can, by derogation, make part of the information entered in this database available to the public.

A Member State must immediately inform the other Member States and the Commission whenever:

  • it suspends or prohibits the trial because the conditions set out in the application cease to be met or because doubts arise as to the safety or scientific justification of the trial;
  • it is of the opinion that the sponsor or investigator is no longer fulfilling his obligations.

Manufacture and import of investigational medicinal products

The manufacture and import of investigational medicinal products is subject to the authorisation referred to Directive 2001/20/EC.

The particulars to appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of investigational medicinal products, must be published by the Commission in the good manufacturing practice guideline on investigational medicinal products to be adopted.

Compliance with good clinical practice

The Member States must appoint Community inspectors. These inspectors carry out inspections on behalf of the Community at relevant sites, notably trial sites and manufacturing sites, in order to check compliance with the provisions of good clinical practice. An inspection report must be prepared.

The European Medicines Evaluation Agency is responsible for coordinating inspections.

Inspections may be carried out in a third country, where there are agreements between the Community and the third country.

Notification of adverse events

The investigator must immediately report all serious adverse events to the sponsor, except for those listed in the protocol or in the investigator’s brochure as not requiring immediate reporting.

Adverse events and abnormalities identified in the protocol as critical to safety evaluations must be reported to the ethics committee and the sponsor. In the event of the death of a participant in a clinical trial, the investigator must supply the sponsor and the ethics committee with any additional requested information.

The sponsor:

  • must ensure that all the relevant information about adverse events are reported to the Member State concerned within the time limits;
  • must maintain detailed records of all suspected adverse events, which must be submitted to the Member States in whose territory the clinical trial is being conducted.

In the event of suspected serious unexpected adverse reactions to an investigational medicinal product occurring on its territory, the Member State must ensure that this event is reported to the European Medicines Evaluation Agency, which must inform the competent authorities of the other Member States.

The Directive is without prejudice to the general civil and criminal liability of the sponsor or the investigator.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2001/20/EC

1.5.2001

OJ L 121 of 1.5.2001

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1901/2006

26.1.2007

OJ L 378 of 27.12.2006

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Directive 2001/20/EC have been incorporated in the original text. This consolidated version is of documentary value only.

Orphan medicinal products

Orphan medicinal products

Outline of the Community (European Union) legislation about Orphan medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Orphan medicinal products

Document or Iniciative

European Parliament and Council Regulation (EC) No 141/2000 of 16 December 1999 on orphan medicinal products [See amending act(s)].

Summary

As a result of the high cost of research and development, the pharmaceuticals industry is reluctant to develop medicinal products intended for the treatment of rare conditions, as well as those called ‘orphan medicinal products’, for which the market is smaller. The aim of this Regulation is to establish a Community procedure for designating orphan medicinal products and to introduce incentives for orphan medicinal products research, development and marketing, for example by granting exclusive marketing rights for a ten-year period.

Orphan medicinal product: criteria for designation

A medicinal product must be designated an orphan medicinal product:

  • if it is intended for the diagnosis, prevention or treatment of a condition affecting no more than five per ten thousand persons in the Community;
    if it is intended for treating a serious or debilitating disease and it is unlikely that without incentives marketing it would generate sufficient return to justify the necessary investment.

Committee for Orphan Medicinal Products

A ‘Committee for Orphan Medicinal Products’, set up within the European Medicines Agency, is responsible for assessing the applications for a medicinal product to be designated an orphan medicinal product and to deliver an opinion to the Commission which makes the decision concerning the designation of a medicinal product as an orphan medicinal product. The Regulation gives the sponsor of the medicinal product the possibility of appealing against the Committee’s opinion. Medicinal products designated as orphan medicinal products are entered on the ‘Community Register of Orphan Medicinal Products’.

Marketing authorisation procedure

Orphan medicinal products are mandatorily subject to the ‘centralised’ marketing authorisation procedure provided for in Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use. The sponsor of an orphan medicinal product can be exempted from payment of the fees payable to the European Medicines Agency.

Exclusive marketing rights

Where marketing authorisation is granted in respect of an orphan medicinal product, the latter will enjoy, with certain exceptions and limitations, exclusive marketing rights for a ten-year period. However, at the request of a Member State, this period can be reduced to six years if that Member State can establish that the conditions justifying the designation as an orphan medicinal product are no longer met or that the price being charged for the medicinal product in question is excessive.

Other incentives

Orphan medicinal products can be eligible for further incentives made available by the Commission and the Member States to support the research, development and availability of orphan medicinal products. More particularly, the measures aid research in favour of small and medium sized enterprises. Member States must inform the Commission of measures taken to this end. The Commission must publish a regular inventory detailing the incentives introduced by the Community and the Member States.

Committee

The Commission shall be assisted by the Permanent Committee for Medicinal Products for Human Use established by Directive 2001/83/EC.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation EC No 141/2000

22.1.2000

OJ L 18 of 22.1.2000

Amending act(s) Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation EC No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EC) No 141/2000 have been incorporated in the original text. This consolidated version is of documentary value only.

Related Acts

 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) [Official Journal L 136 of 30.04.2004].

This Regulation amends, improves and replaces Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Commission Regulation (EC) No 847/2000 of 27 April 2000, laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’ and ‘clinical superiority’ [Official Journal L 103 of 28.04.2000].

Cosmetic products

Cosmetic products

Outline of the Community (European Union) legislation about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal welfare

Cosmetic products (from 2013)

Document or Iniciative

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance).

Summary

Cosmetic products are substances * or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Free movement of these products in the internal market is permitted if they comply with this Regulation.

Market surveillance

A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.

In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.

In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.

If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.

Limitations for certain substances

The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.

The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.

Consumer information

Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:

  • the name or registered name and the address of the responsible person;
  • the country of origin for imported products;
  • the weight or volume of the content at the time of packaging;
  • a use-by date for products kept in appropriate conditions;
  • precautions for use, including for cosmetics for professional use;
  • the batch number of manufacture or the reference for identifying the cosmetic product;
  • the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

The language of the information shall be determined by the Member State where the product is made available to the end user.

Animal testing

Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:

  • finished products,
  • ingredients or combinations of ingredients.

The Regulation also prohibits the placing on the European Union market of:

  • products where the final formulation has been the subject of animal testing;
  • products containing ingredients or combinations of ingredients which have been the subject of animal testing.

A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics *.

In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.

Committee procedure

The Commission shall be assisted by the Standing Committee on Cosmetic Products.

Context

This Regulation recasts Directive 76/768/EEC due to the many amendments made to it and the new amendments that were required.

The new Regulation shall apply in 2013. However, some of its provisions will apply from 1 December 2010: they concern substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR).

Key terms
  • Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Toxicokinetics: study of the long-term effects of toxic substances in the body.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1223/2009

11.7.2013

1.12.10 (Articles 15 paragraphs 1 and 2, Articles 14, 16, 31 and 32)

11.1.2013 (Article 16, paragraph 3, second section)

OJ L 342 of 22.12.2009


Another Normative about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Animal welfare

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/ECof 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].


Another Normative about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Internal market > Pharmaceutical and cosmetic products

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/EC

of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].