Tag Archives: Pharmaceutical product

A renewed vision for the pharmaceutical sector

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

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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

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.

Placing of plant protection products on the market

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Placing of plant protection products on the market

Outline of the Community (European Union) legislation about Placing of plant protection products on the market

Topics

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

Food safety > Plant health checks

Placing of plant protection products on the market

Document or Iniciative

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.

Summary

The Regulation confirms the importance that the European Commission places on a higher level of health and environmental protection, whilst seeking to harmonise the placing of plant protection products * on the market. Furthermore, it aims to improve agricultural production.

The scope of this Regulation covers plant protection products and their active substances *.

The Regulation lays down approval criteria for active substances. An active substance shall be approved if it fulfils the criteria detailed in points 2 and 3 of Annex II to the Regulation. These criteria relate to the efficacy of the substance, its composition, its characteristics, the methods of analysis available, the impact on human health and the environment, ecotoxicology and the relevance of metabolites and residues. As such, an active substance shall only be approved if it is not classified as category 1A or 1B mutagenic, carcinogenic or toxic for reproduction, and is not considered to have endocrine disrupting properties. Furthermore, an active substance which is considered to be a persistent organic pollutant, or as persistent, bioaccumulative and toxic, or even as a very persistent and very bioaccumulative substance, shall not be approved.

The first approval is valid for a limited period which cannot exceed ten years and may be subject to certain conditions or restrictions regarding, for example, the purity of the active substance, the intended crop and the category of user.

Authorisation to place plant protection products on the market remains the responsibility of Member States. Applications are submitted to the Member State where the product is intended to be placed on the market for the first time. Applications shall be accompanied by two dossiers containing all the information available to enable the potential effects of the plant protection product on human and animal health, and the possible impact on the environment, to be assessed. The information provided by the applicant or the producer may be protected by a confidentiality clause if it constitutes an industrial or trade secret.

The time required to examine the application for authorisation to place a plant protection product on the market is limited to a period of twelve months, commencing on the date that the Member State receives the application. During this period, the Member State shall check whether the product concerned satisfies the authorisation conditions. If further information is required, the Member State may extend the initial assessment period in order to allow the applicant time to provide it. This period may not exceed six months and shall expire when the Member State receives the additional information. Where at the end of that period, the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.

Authorisation for placing on the market is valid for 10 years and may be renewed. A Member State may review an authorisation at any time if it no longer complies with one of the pre-conditions for placing on the market. Should this be the case, a Member State may withdraw or amend the authorisation.

The principle of mutual recognition established in this Regulation enables the holder of an authorisation to place the product on the market in another Member State insofar as the agricultural, plant health and environmental conditions are comparable in the regions concerned. However, the Member State may provisionally limit or ban the movement of a product on its territory if the product in question presents a risk to human or animal health, or to the environment.

In order to ensure protection for certain crops, the Regulation enables the holder of an authorisation for a plant protection product which has already been authorised in the Member State concerned, to request that the authorisation be extended to minor uses not yet covered by that authorisation. These extensions of use are also covered by the principle of mutual recognition.

Member States shall update the information on authorised or withdrawn plant protection products at least once every three months. This information shall be accessible to the public.

A provisional authorisation may be granted for the placing on the market of plant protection products containing an active substance which has not yet been approved. The provisional authorisation shall be granted for a period not exceeding three years.

The classification, labelling and packaging of plant protection products is also subject to the requirements provided for by Directive 1999/45/EC regarding dangerous preparations. The packaging of the aforementioned products should prevent consumers from using the products incorrectly.

Member States shall carry out official controls in order to enforce compliance with this Regulation. They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the report relates. The Commission shall call on experts to carry out general and specific audits in the Member States. The aim of these audits is to verify the official controls carried out by the Member States.

The Commission may adopt emergency measures in order to restrict or prohibit the use and/or sale of a plant protection product if it is likely to constitute a serious risk to human or animal health or the environment, and that such a risk cannot be contained by the Member State(s) concerned.

Context

On 14 June 2011, this Regulation shall repeal and replace:

Directive 79/117/EEC concerning prohibited plant protection products; and
Directive 91/414/EEC concerning authorised plant protection products.

Key terms of the Act
Plant protection product: products consisting of or containing active substances, safeners or synergists, and intended for one of the following uses: protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives; destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants; checking or preventing undesired growth of plants, except algae. Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

Key terms of the Act

Plant protection product: products consisting of or containing active substances, safeners or synergists, and intended for one of the following uses:
1. protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;
2. influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient;
3. preserving plant products, in so far as such substances or products are not subject to special Community provisions on preservatives;
4. destroying undesired plants or parts of plants, except algae unless the products are applied on soil or water to protect plants;
5. checking or preventing undesired growth of plants, except algae.
Active substances: substances or micro-organisms, including viruses, having general or specific action against harmful organisms or on plants, parts of plants or plant products.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 1107/2009	14.12.2009	–	OJ L 309 of 24.11.2009

Essential medicines for developing countries

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Essential medicines for developing countries

Outline of the Community (European Union) legislation about Essential medicines for developing countries

Topics

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

Development > Sectoral development policies

Essential medicines for developing countries (HIV/AIDS, tuberculosis and malaria)

Document or Iniciative

Council Regulation (EC) 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines.

Summary

Scope

This Regulation applies to any pharmaceutical product used in the prevention, diagnosis and treatment of the following communicable diseases: HIV/AIDS, malaria and tuberculosis. It does not apply to goods of a non-commercial nature contained in travellers’ personal luggage for personal use within the limits laid down in respect of relief from customs duty.

The list of countries of destination can be found in Annex 2 to the Regulation. There are 76 countries listed.

Principle of tiered pricing

In order for pharmaceutical products to qualify as tiered priced products, their manufacturers or exporters of products must submit applications to the Commission. This application must specify:

the product’s name and composition as well as sufficient information to verify which disease it is preventing, diagnosing or treating;
the proposed price;
the countries of destination.

If the Commission, assisted by a committee of representatives of the Member States, decides that the application fulfils the criteria set out in the Regulation, the product is added to Annex 1 and the applicant informed within 15 days of the date of the decision.

Setting tiered prices

When setting a tiered price, the applicant manufacturer or exporter has two options:

25 % of the average ex-factory price charged in OECD markets;
the direct production costs plus 15 %.

General obligation

It is illegal to import into the Community tiered priced products for the purposes of entry, release for free circulation, re-export, placing under suspensive procedures or placing in a free-zone or free warehouse.

Identification of tiered priced products: marking with a logo

Once a product has been approved as a tiered priced product the manufacturer and exporter affix a logo (see Annex 5) on all packaging, products and documents used in connection with the approved product.

Manufacturers and exporters of tiered priced products sold in the poorest developing countries may, in addition, identify these products by affixing the text “Approved as tiered priced product by EC under Regulation …….” in any of the official languages of the European Union on any packaging or by differentiating the product in a way as may seem fit.

Any additional information (means of transport, trading routes, batch-numbers, etc.) available to the exporter should be made available to the customs authorities to assist them in identifying tiered priced products.

Controls performed by the Member States’ customs authorities

The customs authorities will suspend the release of, or detain, tiered priced products for as long as is necessary to obtain a final decision from the competent authorities on the nature of the goods in question.

If imported products are recognised by the competent authority as tiered priced products, that authority will issue a decision instructing the customs authority to destroy these products unless the importer is prepared to make the goods available for humanitarian purposes to the benefit of countries listed in Annex 2. Destruction is normally carried out at the expense of the importer but in any case without cost to the exchequer.

Where imported products are found not to qualify as tiered priced products as defined in this Regulation, the competent authority issues a decision to that effect enabling the customs authority to release the products to the consignee.

Monitoring the volume of exports of tiered priced products

Manufacturers and exporters are obliged to submit annual reports to the Commission on the volume of sales of each tiered priced product. On the basis of these reports, the Commission reports to the Council on the volumes exported.

Intellectual property law

This regulation has been laid down in parallel with the debate in the WTO’s TRIPs (Trade-Related Aspects of Intellectual Property Rights) Council on the possibility of allowing the developing countries, in health emergencies, to obtain compulsory licences to manufacture the medicines they need.

If the countries in question obtain the medicines they need through tiered pricing, as the proposal for a Regulation suggests, they will not need such compulsory licences.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) 953/2003	4.6.2003	–	OJ L 135 of 3.6.2003

Subsequent amendments and corrections to Regulation (EC) 953/2003 have been incorporated in the basic text. This consolidated version has a purely documentary value”.

Orphan medicinal products

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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].

Pharmaceutical and cosmetic products

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Pharmaceutical and cosmetic products

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

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.

Single Market and the pharmaceutical industry

A renewed vision for the pharmaceutical sector
Parallel imports of proprietary medicinal products
A call for action to strengthen the European-based pharmaceutical industry for the benefit of the patient
IMI Joint Undertaking

Common provisions for medicines for human and veterinary use

Authorisation and supervision of medicinal products – European Medicines Agency
Good laboratory practice: tests on chemical substances
Good laboratory practice: inspection and verification of laboratory studies on all chemicals
Colouring matters for medicinal products (recast)
Supplementary protection certificate for medicinal products
Protection of laboratory animals
European Pharmacopoeia

Medicinal products for human consumption

Community code relating to medicinal products for human use
Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
Advanced therapy medicinal products
Medicinal products for paediatric use
Price of medicinal products for human use: pricing and health insurance
Good clinical practice
Orphan medicinal products
Pharmaceutical Committee

Medicinal products for veterinary use

Community code relating to veterinary medicinal products
Good manufacturing practice for veterinary medicinal products
Residues of veterinary medicinal products in foodstuffs of animal origin
Preparation and marketing of medicated foodstuffs for animals

Cosmetic products

Cosmetic products (from 2013)
Cosmetic products (until 2013)

Patents and invention protection

Community patent
Legal protection of biotechnological inventions
Patent law in the field of biotechnology and genetic engineering: implementation report (2002)
Agreement on intellectual property rights relating to trade and pharmaceutical patents

Multilateral trade

Essential medicines for developing countries (HIV/AIDS, tuberculosis and malaria)
Compulsory licensing system for the production and export of generic medicinal products to developing countries
Duty free treatment

Drug precursors: internal aspects

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Drug precursors: internal aspects

Outline of the Community (European Union) legislation about Drug precursors: internal aspects

Topics

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

Customs

Drug precursors: internal aspects

Document or Iniciative

Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors [See amending act(s)].

Summary

Effective control of chemicals used in the illicit manufacture of narcotic drugs and psychotropic substances is an important tool in combating drug trafficking. However, these chemicals (known as “precursors”) also have legal and legitimate industrial uses. Therefore, it is necessary to recognise and protect the legal trade in these substances, while discouraging their diversion for illicit purposes.

The objective is to strike a balance between taking action to prevent the manufacture of illegal drugs and avoiding barriers to the legal trade in chemicals.

Measures to control precursors

This regulation establishes harmonised measures for controlling and monitoring within the European Union (EU) certain chemical substances that are frequently used in the illicit manufacture of narcotic drugs. It defines “scheduled substances” * in accordance with Article 12 of the United Nations (UN) Convention (see below). For these scheduled substances, the regulation contains provisions relating to licences, customer declarations and labelling. A monitoring procedure is put in place to prevent obstacles to the free trade in these substances between EU countries.

At the same time, the regulation also defines “non-scheduled substances” * in accordance with Article 12 of the UN Convention. For these substances, the Commission draws up guidelines establishing a more flexible control system than the one applicable to scheduled substances.

Under the regulation, operators * must immediately notify the competent authorities of any circumstances, such as unusual orders or transactions involving scheduled substances to be placed on the market *, which suggest that such substances might be diverted for the illicit manufacture of narcotic drugs or psychotropic substances.

Obligations of operators

Operators wishing to place on the market substances scheduled as precursors (categories 1 or 2 of Annex I) have the following obligations:

to appoint an officer responsible for the trade, and to notify the competent authorities of the name and contact details of that officer;
to declare the addresses of the premises at which they manufacture or from which they trade in these substances (for category 2);
to obtain a licence from the competent authorities for possession of substances listed in category 1 (special licences may be granted to pharmacies, dispensaries of veterinary medicine, certain types of public authorities or armed forces);
to ask customers to sign a declaration specifying the use(s) made of the substance provided to them;
to supply scheduled substances only to natural or legal persons in possession of a licence for possession of such substances (for category 1);
to affix a label to scheduled substances before they are transported, showing the name, quantity and weight of the substance and the name and address of the supplier and the recipient.

To prevent creating unnecessary barriers to trade, the requirements for scheduled substances in category 2 are less restrictive than for those in category 1, particularly where the quantities involved do not exceed those indicated in Annex II.

Assisted by a committee, the Commission draws up and keeps updated a list of substances to monitor. EU countries must distribute these lists to operators.

This regulation repeals Council Directive 92/109/EEC, Commission Directives 93/46/EEC, 2001/8/EC and 2003/101/EC, and Commission Regulations (EC) Nos 1485/96 and 1533/2000.

Background: internal and external aspects of the fight against drugs

In 1990, the UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances was adopted by the EU through Council Decision 90/611/ EEC. Article 12 of the UN Convention required measures to be taken to monitor the manufacture and distribution of precursors. As regards the external aspect of this requirement, i.e. monitoring the trade in precursors between EU and non-EU countries, the requirements of Article 12 have been met by Council Regulation (EEC) No 111/2005.

Key terms used in the act
Scheduled substance: any substance listed in Annex I liable to be used for the illicit manufacture of narcotic drugs and psychotropic substances, including mixtures and natural products containing such substances. This excludes medicinal products, pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means. Non-scheduled substance: any substance which, although not listed in Annex I, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances. Placing on the market: any supply, whether in return for payment or free of charge, of scheduled substances in the EU; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the EU. Operator: any natural or legal person engaged in the placing on the market of scheduled substances.

Key terms used in the act

Scheduled substance: any substance listed in Annex I liable to be used for the illicit manufacture of narcotic drugs and psychotropic substances, including mixtures and natural products containing such substances. This excludes medicinal products, pharmaceutical preparations, mixtures, natural products and other preparations containing scheduled substances that are compounded in such a way that they cannot be easily used or extracted by readily applicable or economically viable means.
Non-scheduled substance: any substance which, although not listed in Annex I, is identified as having been used for the illicit manufacture of narcotic drugs or psychotropic substances.
Placing on the market: any supply, whether in return for payment or free of charge, of scheduled substances in the EU; or the storage, manufacture, production, processing, trade, distribution or brokering of these substances for the purpose of supply in the EU.
Operator: any natural or legal person engaged in the placing on the market of scheduled substances.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 273/2004	18.8.2005	–	JO L 47 of 18.2.2004

Amending act(s)	Entry into force	Deadline for transposition in the Member States	Official Journal
Regulation (EC) No 219/2009	20.4.2009	–	OJ L 87 of 31.3.2009

Related Acts

Report from the Commission to the Council and the European Parliament of 7 January 2010 pursuant to Article 16 of Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 and to Article 32 of Council Regulation (EC) No 111/2005 on the implementation and functioning of the Community legislation on monitoring and control of trade in drug precursors [COM(2009) 709 final – Not published in the Official Journal].
This report evaluates the implementation as well as the functioning of Regulations (EC) Nos 273/2004 (above) and 111/2005.
Based on data received form EU countries, the Commission’s evaluation concludes that the legal framework for controlling trade generally provides measures that are proportionate for preventing the diversion of drug precursors without obstructing their legitimate trade. The well-functioning cooperation between operators and competent authorities has greatly contributed to this. Furthermore, the EU guidelines for the chemical industry, together with a new eLearning course for economic operators, complements well this legal framework.
EU countries have applied the common licensing system for category 1 precursors satisfactorily and it functions effectively for the competent authorities as well as for the industry. However, the registration requirement for category 2 precursors might have certain weak points for properly controlling, and preventing diversion in the trade of these substances. In addition, certain provisions (e.g. relating to customer declarations or criteria for determining mixtures) are interpreted differently by EU countries. Other difficulties concern the insufficient rate of reporting by operators to competent authorities and certain aspects of the legislation on external trade, such as inflexible time limits for pre-export notifications and lack of simplified authorisation procedures.
Consequently, the report makes the following recommendations:

enhance the harmonised application of the legislative framework by EU countries, especially by sharing best practice;
improve reporting, for example by increasing the frequency with which operators must report to competent authorities;
possibly modify existing legislation to strengthen controls on category 2 precursors;
strengthen controls on pharmaceutical preparations/medicinal products containing ephedrine or pseudo-ephedrine that transit through the EU;
modify the procedural requirements to achieve a level of controls that is proportionate to the risk of diversion.

Commission Regulation (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and for Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors [Official Journal L 202 of 03.08.2005].
This regulation lays down rules for the implementation of the abovementioned regulations as regards the responsible officer, the licensing and registration of operators, the provision of information, pre-export notifications and authorisation of exports and imports in the field of drug precursors.