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Community code relating to medicinal products for human use

Community code relating to medicinal products for human use

Outline of the Community (European Union) legislation about Community code relating to medicinal products for human 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

Community code relating to medicinal products for human use

Document or Iniciative

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 [See amending acts].

Summary

The code applies to all medicinal products for human use, except for:

  • medicinal products prepared in a pharmacy in accordance with a medical prescription (‘magistral formula’);
  • medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia (‘officinal formula’);
  • medicinal products intended for research and development trials;
  • intermediate products intended for further processing;
  • radionuclides in the form of sealed sources;
  • whole blood, plasma or blood cells of human origin;
  • innovative therapeutic medicinal products prepared on an as-needed basis, pursuant to specific quality standards, and used in the same Member State, in a hospital, under the professional responsibility of a doctor, to carry out a given medical prescription.

This code also applies to the manufacture of medicinal products exclusively intended for export, as well as intermediate products, active substances and excipients.

Marketing authorisation procedure

No medicinal product (with the exception, under certain conditions, of radiopharmaceuticals prepared at the time of use) may be placed on the market of a Member State unless an authorisation has been issued by the competent authorities of that Member State or by the European Medicines Agency (the ‘Agency’).

Only applicants established in the Community may be granted a marketing authorisation.

Certain particulars and documents must be included with the authorisation request, namely:

  • the name and constituents of the medicinal product;
  • the manufacturing method;
  • therapeutic indications, contra-indications and side-effects;
  • posology, method and route of administration;
  • expected shelf-life, precautionary and safety measures during storage and administration of the medicinal product;
  • disposal of waste;
  • the risk to the environment;
  • a description of control tests employed by the manufacturer;
  • the results of pharmaceutical, pre-clinical and clinical tests;
  • a summary describing the applicant’s system of pharmacovigilance;
  • a copy of any marketing authorisation obtained in another Member State or non-member country.

Notwithstanding the previous paragraph and without prejudice to the law relating to intellectual and commercial property, applicants are not obliged to provide the results of pre-clinical or clinical tests or clinical trials if they can show that:

  • the medicinal product is a generic of a reference medicinal product which has been authorised for not less than eight years in a Member State or in the Community;
  • the active substances of the medicinal product have had a well established medicinal use in the Community for at least ten years, with an acceptable level of safety.

Homeopathic medicinal products may be subject to a special, simplified authorisation or registration procedure, provided they satisfy the following criteria:

  • they are administered orally or externally;
  • there is no specific therapeutic indication on the labelling of the medicinal product or in any information relating thereto;
  • there is a sufficient degree of dilution to guarantee the safety of the medicinal product.

When examining a marketing application for a medicinal product (homeopathic or otherwise), the competent authority of the Member State:

  • must verify whether the procedures for issuing a marketing authorisation have been complied with;
  • may have the medicinal product, its raw materials and, if necessary, intermediate products or other constituents tested by a laboratory;
  • may ask the applicant to complete the dossier by submitting certain items referred to in the Directive.

When a marketing authorisation is granted, the competent authority of the Member State concerned must inform the holder that it accepts the summary of the product’s characteristics. It must ensure that the information in the summary is consistent with that approved in connection with the issuing of the authorisation, and must prepare an evaluation report.

In the event of changes to the terms of marketing authorisations, the Commission adopts appropriate provisions by means of an implementing Regulation.

In exceptional circumstances and following consultation with the applicant, an authorisation may be granted subject to certain conditions relating mainly to the safety of the medicinal product, notification of any incident associated with its use, and the measures to be taken. Such authorisation is granted only where the applicant can show that he is unable to provide comprehensive information concerning the safety and efficacy of the medicinal product under normal conditions of use.

Once the authorisation has been delivered, the competent national authority may impose an obligation on the holder to perform a post-authorisation safety or efficacy study.

The authorisation is valid for five years and is renewable. Following issue of the authorisation the holder must take account of scientific and technical progress and ensure that the medicinal product is manufactured and checked by means of generally accepted scientific methods. The competent authority must approve any changes to the product. Once the marketing authorisation has been renewed, it is valid for an unlimited period.

The marketing authorisation application will be rejected if it appears that:

  • the risk-benefit ratio is not seen as favourable (safety criterion);
  • its therapeutic effect is insufficiently substantiated (this efficacy criterion does not apply to homeopathic medicinal products);
  • its qualitative and quantitative composition is not as declared (quality criterion);
  • the particulars and documents which accompany the application are inconsistent with the provisions of the Directive.

The duration of the procedure for granting an authorisation to place a medicinal product (homeopathic or otherwise) on the market may not exceed 210 days.

This Directive sets up a Coordination Group tasked with examining:

  • any questions relating to the marketing authorisation of a medicinal product in two or more Member States;
  • any pharmacovigilance issues for authorised medicinal products;
  • any questions concerning amendments to marketing authorisations issued by Member States.

The role of secretariat of this Coordination Group will be carried out by the Agency.

Mutual recognition procedures and decentralised procedure

In order to be granted a marketing authorisation for a medicinal product in more than one Member State, the applicant must submit an application based on an identical dossier in those Member States (decentralised procedure). The applicant requests that one of the Member States act as “reference Member State” and prepare an assessment report on the medicinal product, a draft summary of the product characteristics as well as a draft label and package leaflet.

If the medicinal product has already been authorised at the time of the application, the authorisation holder may submit a request for recognition of this authorisation to other Member States (mutual recognition procedure). He must inform the Member State which has issued the authorisation (‘reference Member State’) of this, as well as the Agency. The reference Member State must forward the assessment report, the summary of product characteristics and the label and package leaflet to the Member States concerned by the application.

In both cases, within 90 days of the receipt of these documents, each Member State concerned must either recognise the decision of the reference Member State or, on the contrary, consider that the medicinal product may present a serious potential risk to public health.

In the latter case, a conciliation procedure is initiated. This may lead to referral to the Committee for Proprietary Medicinal Products (‘the Committee’) if the disagreement between the Member States is not resolved.

Matters may be referred to the Committee by a Member State, an authorisation holder or the Commission, when a medicinal product has been the subject of several market authorisation applications and the Member States have adopted divergent decisions in regard to those applications. It must issue an opinion within 90 days of the date on which the matter was referred to it by the Agency.

The Member States, the Commission, the applicant or the holder of the marketing authorisation may also refer the matter to the Committee in specific cases where the interests of the European Union (EU) are involved, before reaching a decision on a request for a marketing authorisation or on the suspension, withdrawal or amendment of an authorisation.

The authorisation holder may appeal against a negative decision by the Committee, in which case the Committee examines whether its opinion must be reviewed within 60 days.

Within 15 days of receipt of the Committee’s opinion, the Commission must prepare a draft of the decision to be taken in respect of the application. It also assumes responsibility for drawing up a final decision, which is sent to all the Member States. The marketing authorisation holder or the applicant are informed accordingly.

Within 30 days of receipt of the final decision concerning a marketing authorisation, the Member States must comply with it and duly inform the Commission and the Agency.

Manufacture and importation

The following operations are subject to authorisation by the Member States:

  • manufacture, dividing up, packaging or presentation of medicinal products within the territories of the Member States (with the exception of operations performed by a pharmacist solely for retail supply);
  • all imports of medicinal products from Non-EU Member Countries.

The Member States must record information relating to the authorisation in a European database managed by the Agency.

In order to obtain manufacturing authorisation, the applicant must:

  • specify the medicinal products to be manufactured and imported, and also the place where they are to be manufactured and/or controlled);
  • have at his disposal appropriate premises, technical equipment and control facilities;
  • have at his disposal the services of at least one qualified person responsible for ensuring that the requirements set out in the marketing authorisation and the legislation in force are met;
  • provide particulars in support of his application.

The competent authority of the Member State may issue a manufacturing authorisation only after having made sure of the accuracy of the particulars supplied. Authorisation may be accompanied by certain obligations. The time taken for the procedure for granting manufacturing authorisation may not exceed 90 days, but the period may be suspended temporarily when the applicant is asked to supply additional data.

The holder of a manufacturing authorisation must:

  • have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned;
  • supply the authorised medicinal products only in accordance with the legislation of the Member States concerned;
  • give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied in connection with his manufacturing application;
  • allow the agents of the competent authority access to his premises;
  • enable the qualified person mentioned above to carry out his duties, and inform the competent authority in the event that this person is replaced;
  • comply with the principles and guidelines of good manufacturing practices for medicinal products and use only those active substances manufactured in line with good manufacturing practices and distributed in accordance with good distribution practices;
  • immediately provide the competent authority and the authorisation holder with any information revealing that the medicinal products covered by his authorisation have been falsified or are suspected of having been falsified;
  • check that the manufacturers, importers or distributors supplying him with active substances are registered with the competent authority in the Member State in which they are established;
  • check the authenticity and quality of active substances and excipients.

Active substances may only be imported under certain conditions:

  • they have been manufactured in line with good practice;
  • they are accompanied by written confirmation from the competent authority in the third country in question.

Importers, manufacturers and distributors of active substances established in the EU must register their businesses with the competent authority of the Member State in which they are established.

Labelling and package leaflet

A number of specific particulars must appear on the outer packaging of medicinal products or, where there is none, the immediate packaging, including:

  • name of the medicinal product, its dose and pharmaceutical form;
  • qualitative and quantitative composition in respect of active substances;
  • pharmaceutical form and contents by weight, volume or dose unit;
  • method of administration;
  • list of excipients, listed in the detailed indications;
  • expiry date;
  • special storage precautions, disposal of unused medicinal products or waste;
  • authorisation number and manufacturing batch number;
  • special warnings;
  • safety measures enabling wholesalers and authorised persons to dispense medicinal products to the public (for medicinal products other than radiopharmaceuticals).

These particulars must be legible, easy to understand and indelible.

Prescription-only medicinal products must be provided with safety measures (unless they are exempted by the Commission). Medicinal products not requiring a prescription shall not need safety measures unless they are listed, by derogation, on a list drawn up by the Commission where a risk of falsification has been identified.

Member States may require the use of certain forms of labelling making it possible to ascertain the price of the medicinal product, the conditions for reimbursement by social security organisations, the legal status for supply, as well as identification and proof of authenticity of the medicinal product.

The packaging of all medicinal products must contain a package leaflet, unless the information required features directly on the outer packaging or on the immediate packaging.

The package leaflet must include certain particulars, including:

  • details permitting identification of the medicinal product;
  • therapeutic indications;
  • information necessary before taking the medicinal product;
  • the necessary and usual instructions for proper use;
  • description of the side-effects observed during normal use of the medicinal product;
  • reference to the expiry date indicated on the packaging;
  • date on which the package leaflet was last updated.

Before issuing a marketing authorisation for a medicinal product, the competent authority must check that the outer packaging, the immediate packaging and the package leaflet comply with the Directive. The same applies to all proposed changes to the labelling or the package leaflet.

The labelling particulars must appear at least in the official language or languages of the Member State where the product is placed on the market.

Specific provisions will apply to the packaging and container of medicinal products containing radionuclides, and to the labelling and package leaflets of homeopathic medicinal products.

Classification of medicinal products

When granting a marketing authorisation, and on the basis of the criteria stipulated in the Directive, the competent authorities must specify the classification of the medicinal product as:

  • a medicinal product subject to medical prescription;
  • a medicinal product not subject to medical prescription.

On the basis of the criteria laid down in the Directive, the competent authorities may subdivide medicinal products belonging to the first category as follows:

  • medicinal products on renewable or non-renewable medical prescription;
  • medicinal products subject to special medical prescription;
  • medicinal products on restricted medical prescription, reserved for use in certain specialised areas.

The authorities of each Member State must draw up a list of medicinal products which may only be issued on medical prescription specifying, if necessary, the category of classification. This list must be updated annually. The changes made to it must be communicated to the Commission.

The competent authorities must re-examine and, where necessary, amend the classification of a medicinal product where new facts are brought to their notice.

Wholesale distribution and resale of medicinal products

Member States must make the wholesale distribution of medicinal products subject to the possession of an authorisation to engage in activity as a wholesaler of medicinal products.

Authorisation is not required if a producer already possesses a manufacturing authorisation for the medicinal products concerned. However, possession of authorisation to engage in activity as a wholesaler in medicinal products does not give dispensation from the obligation to possess a manufacturing authorisation. Distributors that do not hold marketing authorisation and import a medicinal product from another Member State must inform the marketing authorisation holder and the competent authority of the Member State concerned of their intention to import said medicinal product.

Wholesale distributors of medicinal products must possess an authorisation to engage in activity as a wholesaler in medicinal products.

The holder of a distribution authorisation must comply with certain requirements, namely:

  • providing officials with access in order to inspect premises, facilities and equipment;
  • procuring medicinal products from persons holding a distribution authorisation;
  • checking that medicinal products received have not been falsified;
  • having an emergency plan which enables a medicinal product to be recalled;
  • record-keeping (purchase/sales invoices, electronic format);
  • implementing an effective risk management system.

Checks on the persons authorised to engage in the activity of wholesaler in medicinal products are carried out by the Member State which has granted the authorisation. A Member State must suspend or revoke the authorisation if the conditions of authorisation are no longer met. It must immediately inform the other Member States and the Commission thereof.

When a Member State considers that, in respect of a person holding an authorisation granted by another Member State, the conditions of authorisation are not, or are no longer met, it must forthwith inform the Commission and the other Member State involved. The latter must take the measures necessary and inform the Commission and the first Member State.

The time taken for the procedure for examining the application for authorisation may not exceed 90 days, unless the applicant has been asked to supply additional data.

The Directive lists the criteria which the holders of the distribution authorisation must meet. In particular, they must have suitable premises and qualified staff and must undertake to fulfil the obligations incumbent on them following issue of the authorisation; these include making the premises available for inspection, supplying medicinal products only to persons who are authorised to supply medicinal products to the public, keeping precise records of all purchase/sales invoices, and having an emergency plan which ensures effective implementation of any withdrawal from the market.

Member States must ensure that persons authorised or entitled to supply medicinal products to the public are able to provide information that makes it possible to trace the distribution path of every medicinal product.

The wholesale distribution of narcotic or psychotropic substances, medicinal products derived from blood, immunological medicinal products and radiopharmaceuticals is subject to more stringent requirements laid down by the Member States.

In consultation with the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC, the Commission must publish guidelines on good distribution practice.

Persons reselling medicinal products must be registered with the competent authority in their Member State and ensure that medicinal products are covered by a marketing authorisation or an authorisation from the competent authorities of a Member State.

Sale to the public by correspondence

Medicinal products may be sold to the public by correspondence, in compliance with Directive 98/34/EC, under the following conditions:

  • the natural or legal person dispensing the medicinal products is authorised to do so in compliance with the legislation of the Member State in which they are established;
  • the natural or legal person dispensing the medicinal products has provided the Member State in which they are established with certain information such as their name, date on which they commenced their activities, and the categories of medicinal products that they sell;
  • medicinal products must be compliant with the national legislation of the destination Member State;
  • the website through which the medicinal products are sold contains contact information for the competent authority, a link to the website of the establishment’s Member State and an official logo pertaining to the sale of medicinal products to the public by correspondence.

Advertising

This Directive defines ‘advertising of medicinal products’ as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products, including advertising to the general public and advertising to persons qualified to prescribe or supply medicinal products, visits by medical sales representatives, supply of samples, sponsorship of promotional meetings and scientific congresses attended by persons qualified to prescribe or supply medicinal products, etc.

Member States must prohibit any advertising of a medicinal product for which a marketing authorisation has not been granted (this prohibition does not apply to homeopathic medicinal products).

The advertising of a medicinal product must encourage the rational use of the product and may not be misleading.

The Directive distinguishes between advertising to the general public and advertising to persons qualified to prescribe or supply medicinal products.

Member States must prohibit the advertising to the general public of medicinal products which:

  • are available on medical prescription only;
  • contain psychotropic or narcotic substances;
  • are not intended for use without the intervention of a medical practitioner.

This prohibition does not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.

Medicinal products may be advertised to the general public if they are intended and designed for use without the intervention of a medical practitioner for diagnosis or for the prescription or monitoring of treatment, and if necessary with the advice of a pharmacist.

Member States must prohibit the direct distribution of medicinal products to the public for promotional purposes. They may also prohibit, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed.

All advertising to the general public of a medicinal product must be clearly identifiable as such and must include at least the following information:

  • name of the medicinal product;
  • the information necessary for correct use of the medicinal product;
  • a specific and legible invitation to read carefully the instructions in the package leaflet.

The Directive bans the inclusion in advertising of medicinal products to the general public of any information which:

  • gives the impression that a medical consultation or surgical operation is unnecessary;
  • compares the medicinal product with other treatments or products;
  • suggests that the health of the subject can be enhanced by taking the medicinal product or affected by not taking it;
  • is directed exclusively or principally at children;
  • refers to a recommendation by scientists, health professionals or persons who, because of their celebrity, could encourage the consumption of medicinal products;
  • suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
  • suggests that the safety or efficacy of the product is due to the fact that it is natural;
  • could, by a description or detailed representation, lead to erroneous self-diagnosis;
  • refers, in improper, alarming or misleading terms, to claims of recovery;
  • uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body.

Advertising aimed at persons qualified to prescribe or supply medicinal products (doctors, pharmacists, etc.) must include:

  • essential information on the medicinal product;
  • the supply classification of the medicinal product.

Member States may also require the inclusion of additional particulars: selling price or indicative price, conditions for reimbursement by social security bodies.

Any documentation relating to a medicinal product supplied to persons qualified to prescribe or supply it must include, besides the particulars listed above, the date on which it was last revised. The information must be accurate, up to date, verifiable and sufficiently complete.

The Directive also contains specifications concerning the training of medical sales representatives and the information requirements and constraints they must respect in their work (ban on granting significant pecuniary advantages or benefits as a promotion technique, restrictions on hospitality at sales promotions, restrictions on the distribution of free samples). For their part, persons qualified to prescribe or supply medicinal products may not solicit or accept any inducement prohibited by the Directive.

Member States must ensure that there are adequate and effective methods to monitor the advertising of medicinal products. These methods must in any event include provisions under which persons or organisations may take legal or administrative action against any advertisements considered to be incompatible with the Directive.

The marketing authorisation holder must fulfil certain obligations to ensure compliance with the Directive (he must provide the monitoring authorities with a sample of all advertisements emanating from his undertaking, meet specific information requirements, etc.).

Member States must lay down the penalties to be imposed should the provisions of the Directive be infringed.

Pharmacovigilance

Member States must establish a pharmacovigilance system to collect information useful for the surveillance of medicinal products with regard to risks they might pose to the heath of patients or public health, in particular adverse reactions in human beings, incorrect use and serious abuse of medicinal products. Member States shall use this pharmacovigilance system to scientifically evaluate this required information with the aim of preventing or reducing risks.

Member States must take all necessary measures to encourage doctors and other healthcare professionals to report suspected adverse reactions to the competent authorities.

Holders of marketing authorisations for medicinal products must implement a pharmacovigilance system equivalent to the system put in place by the Member States. Holders must:

  • implement a risk management system for each medicinal product;
  • monitor the results of risk reduction measures;
  • update the risk management system.

As regards pharmacovigilance, the Member States have obligations of transparency and communication. They must therefore manage a national website on medicinal products which is linked to the European medicinal product website established by Regulation (EC) No 726/2004. The purpose of this website is to communicate, in particular, public assessment reports, risk management summaries and information on the adverse effects of medicinal products.

If marketing authorisation holders wish to disseminate information on pharmacovigilance issues, they must first inform the competent national authorities, the European Medicines Agency and the Commission.

Marketing authorisation holders must notify the Eudravigilance database, introduced by Regulation (EC) No 726/2004, of all suspected serious adverse effects brought to their attention in the EU or a third country, within 15 days of receiving such information. They must also notify the Eudravigilance database of any suspected serious adverse effect coming to light in the Union with 90 days of becoming aware of the occurrence.

For their part, the Member States must ensure that serious side-effect notifications are also brought to the attention of the Agency and the authorisation holder.

The Directive empowers a Member State to recommend the amendment, suspension or withdrawal of marketing authorisation following evaluation of the pharmacovigilance data.

A Member State or the Commission must initiate a European assessment procedure where emergency measures are considered necessary following the assessment of pharmacovigilance data, in any of the following situations in which the Member State or the Commission envisages:

  • suspending or withdrawing a marketing authorisation;
  • prohibiting the dispensing of a medicinal product;
  • refusing the renewal of a marketing authorisation;
  • notifying a new contra-indication.

The Agency must then determine whether the safety problem affects all medicinal products in the same range or the same therapeutic category, and initiate scientific assessment.

The Commission may request that provisional measures be taken. The procedure leads to harmonised measures being adopted throughout the European Union for the medicinal products concerned.

Monitoring of post-authorisation safety studies

This type of monitoring applies to non-interventional post-authorisation safety studies organised by the marketing authorisation holder.

Before carrying out a study, the marketing authorisation holder submits a draft protocol to the Pharmacovigilance Risk Assessment Committee and the competent national authority in their Member State. The study may only be undertaken after approval has been given by the Committee or competent national authority.

Once the study has been completed, a final report must be submitted to the competent national authority or the Pharmacovigilance Risk Assessment Committee. The Committee may also make recommendations, after which the Member States agree on a position to be adopted in this regard. The resulting agreement is then published on the website set up by the Regulation which established the European Medicines Agency.

Implementation, delegation and guidelines

The Commission adopts implementing pharmacovigilance measures concerning, in particular:

  • the content of the permanent dossier in the pharmacovigilance system;
  • minimum requirements for the pharmacovigilance quality system;
  • minimum requirements for the monitoring of information in the Eudravigilance database.

In cooperation with the competent authorities and other interested parties, the Agency prepares guidelines on good pharmacovigilance practice for the competent authorities and marketing authorisation holders.

Medicinal products derived from human blood and plasma

Member States must take all the measures necessary to:

  • prevent the transmission of infectious diseases by medicinal products manufactured on the basis of human blood or plasma;
  • promote Community self-sufficiency in human blood or plasma by encouraging unpaid donations.

Monitoring and sanctions

The competent authorities of each Member State, in cooperation with the Agency, must ensure, by means of regular inspections (inspection of manufacturing establishments and laboratories, sampling, examination of documents), and if necessary by unannounced inspections, that the legal requirements governing medicinal products are complied with. This cooperation also involves sharing information with the Agency concerning inspections planned and carried out by manufacturers established in the EU or in non-Member States, as well as medicinal product wholesalers.

Inspections are carried out by officials authorised to:

  • inspect establishments selling or manufacturing medicinal products, active substances or excipients;
  • take samples;
  • examine all documents relating to the inspection;
  • inspect premises, archives, documents and the permanent dossier in the pharmacovigilance system for the marketing authorisation holder.

Member States may also request that an official laboratory analyse samples.

The Member States must ensure that the supply of a medicinal product is banned and the medicinal product is withdrawn from the market if it appears that:

  • the product is harmful;
  • it is lacking in therapeutic efficacy;
  • the risk-benefit ratio is not favourable;
  • the product’s qualitative and quantitative composition is not as declared;
  • the controls have not been carried out.

The competent authority of a Member State must withdraw or suspend the manufacturing authorisation where the conditions required for obtaining such authorisation are no longer fulfilled and if the manufacturing of the medicinal product does not correspond to information provided.

The Member States must put in place a system aimed at preventing medicinal products suspected of being harmful to health from being dispensed to patients.

However, the competent authority may authorise the dispensing of a medicinal product in exceptional circumstances and for a transitional period to patients who are already being treated with that medicinal product.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 2001/83/EC

18.12.2001

OJ L 311, 28.11.2001

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

Directive 2002/98/EC

8.2.2003

8.2.2005

OJ L 33, 8.2.2003

Directive 2003/63/EC

30.6.2003

31.10.2003

OJ L 159, 27.6.2003

Directive 2004/24/EC

30.4.2004

30.10.2005

OJ L 136, 30.4.2004

Directive 2004/27/EC

30.4.2004

30.10.2005

OJ L 136, 30.4.2004

Regulation (EC) No 1901/2006

26.1.2007

OJ L 378, 27.12.2006

Regulation (EC) No 1394/2007

30.12.2007

OJ L 324, 10.12.2007

Directive 2008/29/EC

21.3.2008

OJ L 81, 20.3.2008

Directive 2009/53/EC

20.7.2009

20.11.2011

OJ L 168, 30.6.2009

Directive 2010/84/EU

20.1.2011

21.7.2012

OJ L 348, 31.12.2010

Directive 2011/62/EU

21.7.2011

2.1.2013

OJ L 174, 1.7.2011

Successive amendments and corrections to Directive 2001/83/EC have been incorporated into the basic text. This consolidated version is for information only.

Related Acts

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 [Official Journal L 262 of 14.10.2003].

Community code relating to veterinary medicinal products

Community code relating to veterinary medicinal products

Outline of the Community (European Union) legislation about Community code relating to veterinary medicinal products

Topics

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

Food safety > Animal health

Community code relating to veterinary medicinal products

Document or Iniciative

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 [See amending acts].

Summary

The Community code relating to veterinary medicinal products will therefore include all the existing provisions governing the production, placing on the market, distribution and use of veterinary medicinal products.

Scope

The code will apply to all veterinary medicinal products, with the exception of:

  • medicated feedingstuffs;
  • inactivated immunological medicinal products which are manufactured from pathogens obtained from an animal from the same holding;
  • medicinal products prepared in a pharmacy in accordance with a “magistral” or “official” formula;
  • medicinal products based on radioactive isotopes;
  • certain additives incorporated into animal feeding stuffs.

To take better account of the emergence of new therapies, such as cell therapies, the definition of veterinary medicinal product was amended in 2004.

Marketing authorisation

No veterinary medicinal product (with the exception, under certain conditions, of those for aquarium fish, cage birds, homing pigeons, terrarium animals and small rodents) may be placed on the European Union (EU) market without a marketing authorisation. In exceptional cases, where required by the health situation or in the event of a serious disease epidemic, derogation from this principle may be permitted.

Medicinal products intended for food producing species may only be granted a marketing authorisation if the active substances they contain are listed in Regulation (EU) No 470/2009 on residue limits of veterinary medicinal products in foodstuffs of animal origin. By way of derogation, medicinal products containing active substances not covered by these provisions may be authorised for equidae which are not intended for human consumption.

No veterinary medicinal product may be administered to animals unless a marketing authorisation has been issued, except for the purpose of product testing.

Where there is no medicinal product for a condition, Member States may exceptionally, in order to avoid causing unacceptable suffering to the animals concerned, permit the administration to non-food producing animals of:

  • veterinary medicinal products authorised for use for another condition or with another animal species;
  • medicinal products for human use;
  • veterinary medicinal products prepared extemporaneously.

Additional conditions apply where such medicinal products are administered to food-producing animals. In particular, the active substances in these medicinal products must be listed in Regulation (EU) No 470/2009 and a minimum waiting time must be observed.

The authorisation is issued by the competent authority of the Member State concerned or, where the centralised procedure established by Regulation (EEC) No 726/2004 applies, by the European Agency for the Evaluation of Medicinal Products (“the Agency”). A marketing authorisation may only be granted to an applicant established in the EU.

Various particulars must be appended to the application for a marketing authorisation (composition and characteristics of the medicinal product, manufacturing method, therapeutic indications, contra-indications and adverse reactions, indication of the withdrawal period in order to limit the level of product residues in foodstuffs, control methods, results of toxicological and pharmacological tests and clinical trials, copy of any marketing authorisation or refusal of marketing authorisation issued in another Member State, etc.).

There are derogations to the requirement to provide certain information with the request for marketing authorisation, such as the law relating to the protection of industrial and commercial property. For example:

  • Applicants are not obliged to provide the results of safety tests, residue tests, pre-clinical trials and clinical trials if they can show that the medicinal product is a generic * of a medicinal product which has been authorised under this legislation for at least 8 years in the EU. Furthermore, a period of 10 years from the authorisation of the reference medicinal product * must be observed before a generic medicinal product can be marketed. This period is extended to 13 years in the case of medicinal products intended for certain species, particularly fish and bees;
  • Applicants are not obliged to provide the results of safety tests, residue tests, pre?clinical trials or clinical trials if they can show that the active substances in the medicinal product have been in well-established veterinary use in the EU for at least 10 years, that their efficacy is recognised and that they demonstrate an acceptable level of safety.

The documents and particulars supplied to the competent authorities must be drafted by experts with the requisite qualifications and analyses must be carried out in accordance with the guidelines in Annex 1.

Particular provisions applicable to homeopathic veterinary medicinal products

Member States may apply a special simplified registration procedure to homeopathic veterinary medicinal products (including homeopathic veterinary medicinal products intended for food-producing animals), provided they meet the following criteria:

  • the route of administration must be that described in the pharmacopoeias currently used officially in the Member States;
  • no specific therapeutic indication must appear on the labelling or in any information relating to the medicinal product;
  • there is a sufficient degree of dilution to guarantee the safety of the medicinal product.

At the time of registration, Member States determine the classification for the dispensing of the medicinal product.

Member States may introduce or retain specific rules for the testing of homeopathic veterinary medicinal products intended for pet animals and exotic species which are non food-producing. In this case, they must notify the Commission of the specific rules in force.

Procedure for marketing authorisation

The marketing authorisation procedure must be completed within 210 days.

Any request for authorisation in more than one Member State must be made in accordance with the centralised authorisation procedure (see below “Authorisations in more than one Member State and mutual recognition”). Thus, Member States must refuse to examine authorisation requests where an initial request is already being examined in another Member State.

If a single request is made, the competent authority of the Member State where it is made:

  • must check the information sent by the applicant;
  • may submit the medicinal product to an official laboratory test and require the applicant to provide further information or substances for testing.

Member States must ensure that manufacturers and importers of veterinary medicinal products from third countries also comply with the Community provisions.

The competent authority must inform the applicant of its decision to issue a marketing authorisation and draw up an assessment report on the dossier. This report must be updated whenever new information becomes available concerning the quality, efficacy or safety of the product.

Exceptionally, and for objective and verifiable reasons, the marketing authorisation may be subject to certain obligations as regards labelling, packaging, notification, etc.

Holders of a marketing authorisation must make any changes needed to ensure that the product is always manufactured and checked by means of up-to-date and generally accepted scientific methods. These changes are subject to the approval of the competent authority of the Member State concerned.

Furthermore, holders must notify the competent authority of certain relevant information concerning the medicinal product (the dates on which marketing begins and ends, expected changes to information provided to users etc.).

In the event of changes to the terms of marketing authorisations, the Commission adopts provisions by means of an implementing Regulation.

The marketing authorisation is valid for a renewable period of five years. After this period, it may be renewed for an unlimited period unless the competent authority decides only to renew it for a further five years.

An authorisation ceases to be valid if:

  • the relevant product is not actually placed on the market within three years;
  • an authorised medicinal product is no longer actually present on the market for a period of three years.

Authorisation will be refused if it is established that:

  • the risk-benefit balance of the veterinary medicinal product is not favourable (safety criterion);
  • it has no therapeutic effect or there is insufficient proof of such effect (efficacy criterion);
  • its qualitative and quantitative composition is not as declared (quality criterion);
  • the withdrawal period recommended by the applicant is not long enough to ensure that the level of residue in foodstuffs is sufficiently low;
  • the labelling or package leaflet is not in compliance with the relevant legislation;
  • the product is offered for sale for a prohibited use;
  • it presents a risk for public, consumer or animal health.

Authorisations in more than one Member State and mutual recognition

Marketing authorisation in more than one Member State may be given in two ways: either an application for authorisation is made in several countries at the same time, or the holder of an authorisation asks for this authorisation to be recognised in other countries:

  • when the same application is made in more than one Member State, the dossier filed in each of the Member States concerned must be identical. This dossier should comply with the standard authorisation procedure (see “Procedure for marketing authorisation” above) and contain the list of countries in which the application is made. The applicant nominates one Member State to act as “reference Member State”. This Member State is given the task of preparing the assessment report for the medicinal product and a draft labelling leaflet within 120 days. It then sends these to the other Member States concerned which have 90 days in which to comment.
  • when a medicinal product has already been authorised, the holder of the authorisation asks the Member State (or one of the Member States if there are several) to send the assessment report, which has been updated if necessary, to the other Member States concerned. They then have 90 days in which to decide whether they recognise this authorisation.

If there is disagreement between one of the Member States concerned and the reference Member State, particularly if one of them considers that the medicinal product poses a risk for human or animal health or for the environment, a conciliation procedure is organised between the Member States concerned. They have 60 days in which to reach an agreement. If no solution has been found by this deadline, the matter is referred to the Committee for Medicinal Products for Veterinary Use. This Committee then has 60 days (which can be extended by up to 90 days) in which to issue a reasoned opinion.

The applicant is entitled to appeal against the Committee’s opinion.

The Member States, the Commission and the holder of the marketing authorisation are notified by the Agency of the Committee’s final opinion.

The Commission takes a final decision on the application under the “regulatory procedure”. It is assisted by the Standing Committee on Veterinary Medicinal Products for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector (“the Standing Committee”).

In specific cases where the interests of the Community are involved, the application may be sent directly to the Committee for Medicinal Products for Veterinary Use.

Any application to vary a marketing authorisation must be submitted to all the Member States which have previously authorised the product concerned. In the event of disagreement, the Member States may institute a conciliation procedure (as described above).

Where a Member State considers that alteration, suspension or withdrawal of an authorisation is necessary to protect human or animal health or the environment, it shall forthwith refer the matter to the Agency for application of the conciliation procedure described above.
Pending a final decision, a Member State may, in exceptional and urgent cases, suspend the marketing and use of a veterinary medicinal product.

The Agency will publish an annual report on the application of the mutual recognition procedures. At least every ten years, the Commission must present a detailed report on the procedures, where necessary suggesting changes.

Manufacture and import

The Member States must make subject to the holding of an authorisation:

  • total or partial manufacture of the veterinary medicinal products and the various processes of dividing up, packaging or presentation (unless these processes are carried out by pharmacists for retail supply);
  • importing of veterinary medicinal products.

Applicants for manufacturing or import authorisations must have suitable premises and equipment and at least one qualified person (as defined in the Directive).

Before issuing the manufacturing or import authorisation, the competent authority of the Member State concerned must establish the accuracy of the particulars supplied by the applicant.

The authorisation granting procedure must not exceed 90 days (30 days for applications to amend an authorisation). This deadline may be suspended where the applicant has been asked to supply further information.

The holder of an authorisation is bound by certain obligations concerning staff, information, controls and premises and must keep detailed records of all veterinary medicinal products supplied by him. These records, and the holders’ premises, must be accessible to the competent authorities. He must also comply with the principles and guidelines of good manufacturing practices for medicinal products laid down in Directive 91/412/EEC.

The Commission (or, where applicable, the Council) is to adopt guidelines of good manufacturing practice for veterinary medicinal products.

Labelling and package leaflet

The containers and outer packages of veterinary medicinal products must carry specific information, viz.:

  • the name and composition of the product;
  • the manufacturer’s batch number and the marketing authorisation number;
  • the name or corporate name and address of the market authorisation holder or the manufacturer;
  • the species of animal for which the product is intended;
  • the withdrawal period for medicinal products for food-producing animals;
  • the expiry date;
  • any special precautions;
  • the words “For animal treatment only”.

In the case of ampoules, certain information on the outer packaging must also be given on the ampoules themselves. Where there is no outer packaging, all the particulars must be shown on the container.

The packaging of the veterinary medicinal product must contain an insert carrying the same information as on the packaging.

Non-observance of these labelling and package insert requirements may lead to the suspension or withdrawal of the marketing authorisation.

The labelling and package inserts of homeopathic veterinary medicinal products must be marked with the words “homeopathic veterinary medicinal product without approved therapeutic indications” and:

  • the scientific name of the stocks and the degree of dilution;
  • the name and address of the marketing authorisation holder;
  • the method of administration;
  • the expiry date;
  • the pharmaceutical form and capacity;
  • any special precautions;
  • target species;
  • the manufacturer’s batch number and registration number.

Possession, wholesale distribution and dispensing

Wholesale distribution of veterinary medicinal products is subject to the holding of an authorisation. The authorisation granting procedure must take no longer than 90 days.

In order to obtain an authorisation for distribution, the applicant must have suitable staff, premises and equipment.

The holder of the authorisation shall have an emergency plan which makes it possible to recall the product.

The holder of the authorisation must keep detailed records of each incoming or outgoing transaction. These records must be kept available for inspection by the competent authorities for at least three years.

The same requirement to keep detailed records applies to retailers. Member States must ensure that retail supply is carried out only by persons permitted to do so under their national legislation.

A prescription is required for dispensing to the public certain medicinal products specified in the Directive:

  • products subject to official (international or European) restrictions;
  • medicinal products for food-producing animals;
  • products in respect of which special precautions must be taken to avoid risks to animals, humans or the environment;
  • products which require a precise prior diagnosis or which may interfere with diagnosis or therapeutic measures;
  • official formulae * intended for food-producing animals;
  • new veterinary medicinal products containing active substances which have been authorised for less than five years.

Specific obligations apply to the possession of and keeping of records on medicinal products with anabolic, anti-infectious, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties.

Under certain conditions, veterinarians providing services in another Member State can take with them small quantities of ready-made veterinary medicinal products (other than immunological products) even if they are not authorised for use in the Member State concerned.

Member States may prohibit the manufacture, import, possession, sale, supply or use of immunological medicinal products if they can show that:

  • the use of these products will interfere with a national disease eradication programme; or
  • the disease for which the medicinal product is intended is largely absent from their country.

Pharmacovigilance

Member States are expected to encourage the reporting of adverse effects to the competent authorities.

They must establish a pharmacovigilance system to collect all useful information on veterinary medicinal products, with particular reference to adverse reactions in animals. This information is to be collated with data on consumption and on the misuse or serious abuse of veterinary medicinal products.

The marketing authorisation holder must appoint an appropriately qualified person responsible for pharmacovigilance. This person must be resident in the European Union and is responsible for managing an information system on adverse reactions and for providing information to the competent authorities.

The authorisation holder must:

  • report any suspected serious adverse reaction to the competent authority (within 15 days);
  • keep detailed records on any other adverse reaction. These records must be submitted to the competent authorities at regular intervals.

Member States must ensure that reports of suspected adverse reactions are brought to the attention of the Agency and the authorisation holder (within 15 days).

The Commission is to draw up guidelines on the adverse reaction notification system.

Where, on the basis of an adverse reaction report, the competent authority of a Member State considers that a marketing authorisation should be altered, suspended or withdrawn, it must forthwith inform the Agency and the authorisation holder. In the event of urgency, the competent authority may suspend the marketing of the veterinary medicinal product concerned.

Monitoring and sanctions

The competent authority may inspect manufacturing and trading establishments and laboratories to ensure that the legal requirements are complied with, including those of manufacturers established in a third country.

Following such an inspection, the officials representing the competent authority report on whether the principles of good manufacturing practice are being complied with. The manufacturers concerned are informed of the content of such reports.

Holders of marketing authorisations for immunological medicinal products must ensure that representative samples are available for tests. Member States may, if they consider it necessary, require these samples to be submitted to an approved laboratory for testing before being placed on the market.

The competent authorities of the Member States shall suspend or withdraw marketing authorisation when it is clear that:

  • the product proves to be very harmful;
  • it lacks therapeutic efficacy;
  • its qualitative and quantitative composition is not as declared;
  • the recommended withdrawal period is inadequate;
  • the product is offered for sale for a prohibited use;
  • the information given is incorrect;
  • the required tests have not been carried out.

The marketing authorisation may also be suspended, withdrawn or amended where:

  • certain necessary changes have not been made to the information in the product dossier;
  • new information has not been communicated to the competent authorities.

Member States must take all necessary measures to ensure that supply of a veterinary medicinal product is prohibited in the following cases:

  • the product proves to be very harmful;
  • it lacks therapeutic efficacy;
  • its qualitative and quantitative composition is not as declared;
  • the recommended withdrawal period is inadequate;
  • the required tests have not been carried out.

The manufacturing authorisation is withdrawn if the requirements valid at the time of application (suitable premises and equipment and at least one qualified person as defined in the Directive) are no longer met.

Member States must take measures to encourage veterinarians or other professionals concerned to report any adverse reaction to medicinal products to the competent authorities.

General provisions

The competent authorities in the Member States are bound by a mutual information obligation. Where there is a serious difference in opinion in respect of a report drawn up following an inspection, the Member States concerned must inform the Commission. The Commission may then ask for a new inspection.

Member States must ensure that the Agency is informed of all decisions concerning marketing authorisations applications.

Marketing authorisation holders must notify the Member States forthwith of any action taken to withdraw or suspend the marketing of a veterinary medicinal product. The Member States are responsible for ensuring that this information is brought to the attention of the Agency and, in the case of products exported to third countries, to the relevant international organisations.

The general mutual information obligation also applies to homeopathic medicinal products.

At the request of a manufacturer or exporter of veterinary medicinal products or of an importing country, Member States will certify that the manufacturer in question holds an authorisation.

Decisions to grant or revoke a marketing authorisation shall be made publicly available.

Member States will not permit foodstuffs for human consumption to be taken from test animals, unless:

  • maximum residue limits have been established (in accordance with Regulation (EU) No 470/2009);
  • a minimum withdrawal period has been established.

Member States shall set up appropriate collection systems for veterinary medicinal products that are unused or expired.

Two annexes are attached to the Community code:

  • Annex I on the requirements and analytical protocol, safety tests, pre-clinical and clinical, for tests of veterinary medicinal products;
  • Annex II listing the Directives repealed by this Directive, together with their successive amended versions.

Background

In November 2001, the Commission presented an important revision of Community legislation on pharmaceutical products. This “legislative package”, which was adopted in March 2004, consists of three instruments:

  • a regulation amending Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Medicines Agency;
  • a directive amending the Community code relating to medicinal products for human use;
  • a directive amending the Community code relating to veterinary medicinal products, which is the subject of this factsheet.
Key terms
  • Generic medicinal product: a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies.
  • Reference medicinal product: a medicinal product authorised in accordance with these regulations;
  • Official formulae: medicinal products prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the end-user

References

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

Directive 2001/82/EC

18.12.2001

OJ L 311 of 28.11.2001

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

Directive 2004/28/EC

30.4.2004

30.10.2005

OJ L 136 of 30.4.2004

Directive 2009/53/EC

20.7.2009

20.1.2009

OJ L 168 of 30.6.2009

Regulation No 470/2009/EC

6.7.2009

OJ L 152 of 16.6.2009

Regulation No 596/2009/EC

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrigenda to Directive 2001/82/EC have been incorporated into the basic text. This consolidated versionis of documentary value only.

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

Transport under the TIR or ATA procedure

Transport under the TIR or ATA procedure

Outline of the Community (European Union) legislation about Transport under the TIR or ATA procedure

Topics

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

Customs

Transport under the TIR or ATA procedure

acquis to take account of the provisions of the agreements regarding these two procedures.

Document or Iniciative

Commission Regulation (EEC) No 2454/93 of 2 July 1993 laying down provisions for the implementation of Council Regulation (EEC) No 2913/92 establishing the Community Customs Code.

Summary

This regulation brings together the provisions for implementing the Community Customs Code in a single text. Part II, Title II, Chapter 9 of this regulation contains the provisions which are applicable to transport under the TIR or ATA procedures. Any matter concerning the application of this regulation may be examined by the Community Customs Code Committee provided for in the Council Regulation on the Customs Code.

Common provisions

When goods are transported inside the Community under TIR or ATA procedures, the Community is considered as forming a single territory for the purposes of the transport operation. For the purposes of using ATA carnets as transit documents, ‘transit’ means the transport of goods from a customs office situated in the customs territory of the Community to another customs office situated within the same territory.

Where, in the course of transport from one point in the customs territory of the Community to another, goods pass through the territory of a third country, the controls and formalities associated with the TIR or ATA procedure are carried out at the points where the goods temporarily leave the customs territory of the Community and where they re-enter that territory. Goods transported under cover of TIR of ATA carnets within the territory of the Community are regarded as non-Community goods *, unless their Community status is duly established.

The TIR procedure

The TIR procedure is an international customs transit system that applies to the transport of goods without intermediate reloading, between a customs office of departure and a customs office of destination, provided that part of the journey is made by road. The procedure allows goods to be transported across international borders without the payment of the duties and taxes that would normally be due at importation or exportation. As the Community is considered as a single territory, the TIR procedure can only be used within the Community where the movement either starts or ends in a third country, or where the goods move between two or more Community countries via the territory of a third country.

Recipients of goods sent under cover of a TIR carnet, if they are established in the Community, may at their request be granted the status of authorised consignee, if they regularly receive goods under the TIR procedure, provided they have not committed any serious or repeated infringements of customs or tax legislation.

Application of the TIR Convention in the Community

Since 1 January 2009, TIR procedure is treated electronically in the Community. Discharge of the TIR procedure in the Community must be carried out by the customs office of entry or departure after they have received confirmation from the office of destination or exit that the operation was terminated within the time limit prescribed by the customs office or entry or departure. If, after the expiry of the time limit for the office of exit or destination to give the information that the operation was terminated, the competent authorities for discharge still have no proof that the TIR operation has been terminated, an enquiry procedure is initiated.

The procedure is initiated immediately if the discharge authorities are informed in advance that the TIR operation has not been terminated, or when they suspect as much. The enquiry procedure is also initiated if it transpires subsequently that proof of the termination of the TIR operation was falsified. If the competent office does not receive the information enabling it to discharge the operation, it informs the guaranteeing association concerned and the holder of the TIR carnet, within 28 days after the start of the enquiry procedure with the customs office of destination or exit when the TIR operation cannot be discharged.

When infringements or irregularities committed during transport under cover of a TIR carnet result in a Community customs debt, the Member State identified as competent to recover duties or impose penalties initiates the procedure for recovery from the debtor.

When a TIR operation is carried out on the customs territory of the Community, any guaranteeing association established in the Community may become liable for the payment of the secured amount of the customs debt relating to the goods concerned in the TIR operation up to a limit per TIR carnet of EUR 60 000 or the national currency equivalent thereof. The guaranteeing association established in the Member State competent for recovery is liable for payment of the secured amount of the customs debt.

Where customs authorities of a Member State decide to exclude a person from the TIR procedure under the provisions of Article 38 of the TIR Convention, this decision shall apply throughout the customs territory of the Community.

The ATA procedure

The ATA carnet is used for temporary importation, transit and temporary admission of goods designed for specific purposes, duty-free and tax-free (such as professional equipment for presentations or trade fairs, for example).

Where offences or irregularities are committed during a transport operation under cover of an ATA carnet in a given Member State, that Member State is identified as competent to recover any duties and impose penalties. Where it is not possible to determine in which territory the offence or irregularity was committed, it is deemed to have been committed in the Member State where it was detected unless proof to the contrary is provided.

Findings made by the competent authorities of the different Member States, in applying this regulation, have the same force throughout the customs territory of the Community. Where necessary, the competent authorities are required to communicate to one another all information relating to TIR or ATA consignments and to any offences or irregularities noted.

Key terms used in the act
  • Community goods refers to goods:
    • entirely obtained in the customs territory of the Community, without the addition of goods from non-member countries or territories which are not part of the customs territory of the Community;
    • from countries or territories not forming part of the customs territory of the Community which have been released for free circulation in a Member State;
    • obtained in the customs territory of the Community either from the goods referred to exclusively in the second indent or from the goods referred to in the first and second indents.
  • Non-Community goods: goods other than those defined as Community goods. Goods reintroduced into the customs territory of the Community after being exported outside that territory are also considered to be non-Community goods.

References

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

Regulation (EEC) No 2454/93

14.10.1993

OJ L 253, 11.10.1993

Successive amendments and corrections to Regulation (EC) No 2454/93 have been incorporated in the basic text. This consolidated version is for reference purposes only.