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

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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.

Supplementary protection certificate for medicinal products

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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

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Colouring matters for medicinal products

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

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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.

Medicinal products for paediatric use

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Medicinal products for paediatric use

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

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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

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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

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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

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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.

Pharmaceutical Committee

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Pharmaceutical Committee

Outline of the Community (European Union) legislation about Pharmaceutical Committee

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Pharmaceutical Committee

Document or Iniciative

Council Decision 75/320/EEC of 20 May 1975 setting up a pharmaceutical committee.

Summary

The Decision sets up, and attaches to the Commission, a Pharmaceutical Committee composed of representatives from the Member States and chaired by a Commission representative. Each national representative is assisted by a deputy who is entitled to participate in meetings of the Committee.

The task of the Committee is to examine any question relating to proprietary medicinal products, in particular questions relating to the application of Directives on the subject, at the request of its Chairman or at the request of the representative of a Member State.

The Commission consults the Committee when preparing proposals for Directives.

There are other advisory committees used by the Commission when making decisions in the pharmaceutical field: the Veterinary Pharmaceutical Committee and the Telematics Committee.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal
Decision 75/320/EEC 20.5.1975 – OJ L 147, 9.6.1975

 

A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

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A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

Outline of the Community (European Union) legislation about A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

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Internal market > Pharmaceutical and cosmetic products

A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient

Document or Iniciative

Communication from the Commission of 1 July 2003 on strengthening the European pharmaceutical industry for the benefit of the patient. [COM(2003) 383 final – Not published in the Official Journal].

Summary

BACKGROUND

The “G10 Medicines Group” was set up in 2001 on the initiative of the Members of the European Commission responsible for the “Enterprise” and “Health and Consumer Protection” Directorates-General. Alongside the two Commission representatives, it is made up of ten experts recruited from the industry, national Ministries of Health, social security organisations and patients groups.

This focus group was asked to recommend ways of improving the performance of the pharmaceutical industry in terms of its competitiveness and its contribution to social and public health objectives.

In accordance with the objectives it was set, the G10 group submitted its final report to the Commission in May 2002.

This contains a set of 14 recommendations prompted by two considerations:

  • the pharmaceutical industry in Europe generates wealth and high quality employment whilst playing a central role in the development of innovation. It can thus make a major contribution to achieving the goals set in Lisbon (a competitive knowledge-based economy, sustainable economic growth, and more and better jobs);
  • the pharmaceutical sector is lagging behind the USA in its ability to generate, organise and sustain innovative processes. In addition, European markets are not competitive enough and R&D expenditure is not growing fast enough.

Faced with this situation, the G10 group pointed out that tackling the growing weaknesses in the EU pharmaceutical industry is both a major industrial policy concern and a key public health objective (to improve the quality, safety and efficacy of medicines for the benefit of the public).

In this communication, the Commission states how it wishes to implement these recommendations and proposes certain actions the Member States could take on matters of national competence.

WORKING FOR THE BENEFIT OF THE PATIENT

Improving patient information

With the steady growth in the demand and use of health information by patients, the information sources on offer (particularly on the Internet) are proliferating. Faced with this new situation, the Commission seeks to improve the quality and reliability of this information and provide a realistic and practical framework to give patients access to objective data.
Following on from its communication in 2002 entitled “Quality criteria for health-related websites”, the Commission proposes looking into the possible development of European seals of approval for such sites.
In addition, as part of the new Public Health Programme (2003-2008), a European Health Portal is being developed which should allow this information to be disseminated to the general public.

To increase public confidence in the information on medicines, the Commission will reflect on establishing a collaborative Public Private Partnership involving representatives from public authorities, industry, health funds, healthcare professionals and patient groups. This partnership could take the form of a small body that would be able to advise and monitor the quality of the information already available. It would also produce guidelines in specific areas to support the work of National and Community regulatory authorities.

Finally, the Commission would like to ensure that patients consume medicines appropriately. To do so, it wishes to ensure that the information contained in the patient information leaflet and on the label (dosage, contra-indications, special precautions for use) are as comprehensible and legible as possible.

Strengthening the role of patients in public-health decision-making

Also under the Public Health Programme (2003-2008), the Commission plans to make funds available to patient groups looking to create a Community umbrella organisation. The Commission would also like these groups to assume a more important role in the development of Community health and medicines policy.

The concept of the relative effectiveness of medicines

The Commission wants to set up a forum where Member States which use relative effectiveness measures to set prices and reimbursement levels for medicines could exchange information on their methods. This would make it possible to analyse whether, on the basis of the national approaches used to calculate the relative effectiveness of a medicine, i.e. the assessment of added therapeutic value (its clinical effectiveness compared to other treatments) and its cost effectiveness, an effective and faster common procedure could be introduced.

Improving pharmacovigilance systems

The Commission wishes to strengthen pharmacovigilance at Community level through the role of the European Medicines Agency (EMEA) which should help coordinate national action and centralise results. The ultimate aim is to enable Member States to benefit from more information about adverse reactions to the use by the general population of a medicine which has previously only been tested during clinical trials.

DEVELOPING THE INDUSTRY’S COMPETITIVENESS

Updating the regulatory structure

In order to improve marketing authorisation procedures, the Commission points out that it would be desirable to shorten dossier assessment times and make greater use, under the centralised procedure, of telematics through EudraNET, the EuroPHARM Database and EudraVigilance.

Access to innovative medicines

The development of innovative medicines with a high added therapeutic value should be encouraged under the 6th Framework Programme for Research.

In addition the Commission, through its proposal for a review of pharmaceutical legislation, has demonstrated its desire to support research into innovative medicines and provide sufficient protection for the exclusivity of the data on such medicines.

The timing of reimbursement and pricing negotiations

The Member States should examine their existing pricing and reimbursement systems to ensure that they operate fully in accordance with the transparency requirements and within the timeframe set by Directive 89/105/EEC (pricing of medicinal products and health insurance systems).

The Commission and Member States should examine the scope for reducing the time taken between granting a marketing authorisation and pricing and reimbursement decisions to the absolute minimum.

For the time being, the prices of medicines are widely divergent amongst Member States as they are set by national administrative decisions. To facilitate market integration, the Commission suggests giving manufacturers the possibility of setting the prices of medicinal products, while negotiating with the Member States the possibility of introducing safeguard mechanisms to contain pharmaceutical expenditure by the State. Such a system is intended to open the way for the free fixing of prices of medicines on the market, as with any other product in the internal market.

Medicines not reimbursed by the State

The Commission asks the Member States to remove price controls on manufacturers that prevent full competition for medicines that are not reimbursed by the State and for those which are not to be sold to the public sector.

The competitive generic medicines market

Generic medicines can provide significant savings to patients and to national healthcare financing systems, which is why the Commission stresses the need to facilitate generic penetration in the different national markets.

In order to put this into effect, the Commission points out that generic producers should be given the opportunity to supply generic medicines to Member States where the reference product is not on their market.

This communication also points out that, as part of the reform of the Community code relating to medicinal products for human use, the Council’s common position suggests the possibility of introducing a marketing authorisation application for a generic and to grant this authorisation in the last two years of the data protection period of the reference product for all products except those falling within the mandatory scope of the centralised procedure. This will allow these products to come onto the market immediately after the end of the ten-year data protection period.

The competitive non-prescription market

To reduce the differences amongst Member States in products classified as non-prescription, the Commission suggests that there be greater consistency in classification decisions.

Moreover, since the reclassification of medicines from prescription to non-prescription status brings benefits to patients, healthcare professionals, governments, healthcare systems and industry alike, the Commission suggests the introduction of a period of data exclusivity where significant clinical or pre-clinical data have been submitted with the application.

Finally, the Commission advocates that the Member States allow the use of the same trademark after reclassification where there is no risk to public health, as this avoids financial costs which may dissuade producers from taking this step.

STRENGTHENING THE SCIENCE BASE

The fragmented nature of European research systems (lack of scientific collaboration among Member States and between the public and private sectors) is hampering R&D activity in the EU and the introduction of innovative processes.
The Commission suggests a very broad range of measures to remedy these problems:

  • taking forward the concept of European virtual institutes of health;
  • creating a genuine European research area as set out in the sixth framework programme for research (scientific cooperation and training to stem the loss of highly-skilled European scientists);
  • an increase in Community research spending to 3% of GDP in the EU by 2010 in line with the strategy agreed at the Barcelona European Council in March 2002;
  • the implementation of a life science and biotechnology action plan (skilled workforce, financial support, networking of biotechnology regions in Europe, developing the size of enterprises in the sector);
  • the creation of a European Centre for Disease Prevention and Control which should become operational no later than 2005;
  • the development of proposals to encourage R&D on diseases which are currently neglected or where R&D is lacking.

The incentives for research which the Commission wishes to introduce also include:

  • the creation of a database on clinical trials and the drafting of detailed guidelines on the principles of good clinical practice as defined in directive 2001/20/EC;
  • the promotion of research into orphan medicines by taking measures on rare diseases;
  • finalisation of the proposal for a regulation on medicines for paediatric use which is expected in 2004;
  • the rapid implementation by all Member States of the Directive on Legal Protection of Biological Inventions and the adoption of the Community patent legislation.

MEDICINES IN AN ENLARGED EUROPEAN UNION

The health status in the future Member States is generally lower than in the rest of the EU and they devote fewer resources to healthcare. Also, the levels of intellectual property protection differ, leading to divergences in price levels, which could cause an increase in parallel imports.

For a limited period after accession, some medicines on the market in the new Member States will not have the same level of intellectual property protection found in the existing Member States. The Accession Treaties were, therefore, amended to include a transitional period prior to the full application of the principle of free movement to prevent the parallel import of pharmaceutical products that lack equivalent intellectual property right protection.

In addition, under the pharmaceutical legislation review, there will be a statutory requirement for parallel importers to inform both the marketing authorisation holder and the competent authorities of their intention to proceed with a parallel import in a given Member State. However, the legal responsibility for enforcing intellectual property rights will remain with the patent holder.

The pharmaceutical legislation review will also allow generic supply of medicines in Member States where there is no reference product on the market, and help to alleviate problems of availability in the new Member States.

Alongside these different measures, the new Member States have been offered practical help to prepare for accession through the Pan European Regulatory Forum (PERF).

THE EXCHANGE OF INFORMATION AMONG MEMBER STATES

In its final report, the G10 Medicines Group recommends the development of a set of EU indicators to cover both industry competitiveness and public health objectives. Benchmarking is no solution to the problems of competitiveness in itself but it will, for the first time, establish a set of agreed EU performance indicators that will provide a comprehensive and objective basis for measuring the implementation of the recommendations and to exchange best practice.

The competitiveness indicators cover four broad areas: supply, demand and the regulatory framework, industry outputs, and macroeconomic factors. The Commission will publish annual tables of competitiveness indicators. This data will thus provide a basis for discussion in the Council, the European Parliament and at International Conferences.

Developing a set of indicators that can monitor the role of the pharmaceutical industry in preventing and treating disease is no easy task. While industry has clearly made a key contribution to public health in a number of areas, it is difficult to quantify in global terms and in terms of individual products or for specific diseases. The Commission is working on the development of a range of indicators in this field which should cover:

  • the availability of pharmaceutical products, compared to other health care inputs, for priority diseases;
  • the significance of available medicines, e.g. in terms of their effectiveness;
  • the identification of those diseases for which there are no effective medicines;
  • the prescription and rational use, at the medical professional and patient level;
  • patient quality issues such as the acceptability of medicines.

FOLLOW-UP MEASURES

Benchmarking follow-up

The Commission undertakes to update and adapt these performance indicators annually and to submit them to the Council and the European Parliament at regular intervals. It also plans to set up a small secretariat to take forward the benchmarking exercise.

Maintaining the momentum of G10

The Commission would like Member States, on a voluntary basis, to communicate national measures that could have an impact on G10 Medicines-related issues.

The Commission invites the Council and the European Parliament, together with other stakeholders, to take forward the key actions highlighted in this Communication

The Commission will support the organisation of annual meetings to follow up this Communication and to verify progress on key actions.

 

European Pharmacopoeia

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European Pharmacopoeia

Outline of the Community (European Union) legislation about European Pharmacopoeia

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

European Pharmacopoeia

Document or Iniciative

Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia.

Summary

On 22 July 1964 Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom signed a Convention, drawn up under the aegis of the Council of Europe, on the elaboration of a European Pharmacopoeia.

The objectives are to harmonise specifications for medicinal substances of general interest to the population of Europe and to hasten the drawing-up of specifications for the growing number of new medicinal substances appearing on the market.

These objectives are met by creating a European Pharmacopoeia comprising monographs which become official standards applicable in the territories of the countries which are Contracting Parties to the Convention.

On 16 November 1989 a Protocol to this Convention was signed in order to enable the European Community to accede to it. It entered into force on 1 November 1992.

The European Pharmacopoeia currently has 37 European members, including the European Union (EU). The 36 member countries are:

  • the EU-15, namely Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom;
  • three of the European Free Trade Association (EFTA) countries, namely Iceland, Norway and Switzerland;
  • the twelve new Member States of the EU, namely Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic, Slovenia, Bulgaria and Romania;
  • the three EU candidate countries, namely Croatia, Turkey and the former Yugoslav Republic of Macedonia;
  • Bosnia and Herzegovina, Serbia and Montenegro.

The European Pharmacopoeia also has 21 observers, including the World Health Organisation (WHO). The 20 observer countries are:

  • seven European countries, namely Albania, Republic of Belarus, Georgia, Kazakhstan, Moldova, the Russian Federation and Ukraine;
  • thirteen non-European countries, namely Algeria, Australia, Brazil, Canada, China, Israel, Madagascar, Malaysia, Morocco, Senegal, Syria, Tunisia and the United States.

The elaboration of the European Pharmacopoeia is undertaken by two bodies:

  • the European Pharmacopoeia Commission, which prepares and adopts the technical decisions relating to monographs. It comprises eminent scientists appointed by each Contracting Party and chosen for their competence in certain fields;
  • the Public Health Committee of the Council of Europe, which exercises administrative authority over the Commission’s activities and sets the date of application of the monographs but cannot interfere with their technical content.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Decision 94/358/EC 16.6.1994 – OJ L 158 of 25.6.1994

 related Acts

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 (l21230) [Official Journal L 311 of 28.11.2001].

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (l21231) [Official Journal L 311 of 28.11.2001].