Considerations on COM(2001)404-3 - Amendment of Directive 2001/82/EC on the EC code relating to veterinary medicinal products - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2001)404-3 - Amendment of Directive 2001/82/EC on the EC code relating to veterinary medicinal products. |
|---|---|
| document | COM(2001)404  |
| date | March 31, 2004 |
(2) The Community legislation so far adopted has made a major contribution to the achievement of the objective of free and safe movement of veterinary medicinal products and the elimination of obstacles to trade in such products. However, in the light of the experience gained, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement.
(3) It is therefore necessary to align national laws, regulations and administrative provisions that contain differences with regard to the basic principles in order to promote the operation of the internal market without adversely affecting public health.
(4) The main purpose of any regulation on the manufacture and distribution of veterinary medicinal products should be to safeguard animal health and welfare as well as public health. The legislation on marketing authorisations for veterinary medicinal products, and the criteria governing the granting of authorisations, are such as to strengthen the protection of public health. That aim should, however, be achieved by means that do not hinder the development of the pharmaceutical industry or trade in veterinary medicinal products within the Community.
(5) Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(5) provided that, within six years of its entry into force, the Commission was required to publish a general report on the experience acquired as a result of the operation of the marketing authorisation procedures laid down in that Regulation and in other Community legal provisions.
(6) In the light of the Commission's report on the experience acquired, it has proved necessary to improve the operation of the marketing authorisation procedures for veterinary medicinal products in the Community.
(7) Particularly as a result of scientific and technical progress in the field of animal health, the definitions and scope of Directive 2001/82/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of veterinary medicinal products. In order to take account both of the emergence of new therapies and of the growing number of so-called 'borderline' products between the medicinal product sector and other sectors, the definition of 'medicinal product' should be modified so as to avoid any doubt as to the applicable legislation when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products. Also, in view of the characteristics of pharmaceutical legislation, provision should be made for such legislation to apply. With the same objective of clarifying situations, where a given product comes under the definition of a veterinary medicinal product, but could also fall within the definition of other regulated products, it is necessary, in cases of doubt and in order to ensure legal certainty, to state explicitly which provisions have to be complied with. Where a product comes clearly under the definition of other product categories, in particular food, feed, feed additives or biocides, this Directive should not apply. It is also appropriate to improve the consistency of the terminology of pharmaceutical legislation.
(8) The veterinary medicinal products sector has a number of very specific features. Veterinary medicinal products for food-producing animals may be authorised only on conditions that guarantee that the foodstuffs produced will be harmless to consumers as regards any residues of such medicinal products.
(9) The costs of research and development to meet increased requirements as regards the quality, safety and efficacy of veterinary medicinal products are leading to a gradual reduction in the range of products authorised for the species and indications representing smaller market sectors.
(10) The provisions of Directive 2001/82/EC also need, therefore, to be adapted to the specific features of the sector, particularly to meet the health and welfare needs of food-producing animals on terms that guarantee a high level of consumer protection, and in a context that provides adequate economic interest for the veterinary medicinal products industry.
(11) In certain circumstances, particularly where certain types of pets are concerned, the need to obtain a marketing authorisation for a veterinary medicinal product in accordance with Community provisions is clearly disproportionate. Moreover, the absence of authorisation to market an immunological product in the Community should not be an obstacle to international movements of certain live animals for the purpose of which binding health measures have to be taken. The provisions on the authorisation or use of such medicinal products to take account of measures to combat certain infectious animal diseases at Community level also need to be adapted.
(12) Evaluation of the operation of market authorisation procedures has revealed the need to revise, in particular, the mutual-recognition procedure in order to improve the opportunities for cooperation between Member States. This cooperation process should be formalised by setting up a coordination group for this procedure and by defining its operation so as to settle disagreements within the framework of a revised decentralised procedure.
(13) With regard to referrals, the experience acquired reveals the need for an appropriate procedure, particularly in the case of referrals relating to an entire therapeutic class or to all veterinary medicinal products containing the same active substance.
(14) Marketing authorisation for veterinary medicinal products should be limited initially to five years. After this first renewal, the marketing authorisation should normally be valid for an unlimited period. Furthermore, any authorisation not used for three consecutive years, that is to say, one which has not led to the placing on the market of a veterinary medicinal product in the Member States concerned during that period, should be considered invalid, in order, in particular, to avoid the administrative burden of maintaining such authorisations. However, exemptions from this rule should be granted when these are justified on public or animal health grounds.
(15) Biological medicinal products similar to a reference medicinal product do not usually meet all the conditions to be considered as a generic medicinal product mainly due to manufacturing process characteristics, raw materials used, molecular characteristics and therapeutic modes of action. When a biological product does not meet all the conditions to be considered as a generic medicinal product, the results of appropriate tests should be provided in order to fulfil the requirements related to safety (pre-clinical tests) or to efficacy (clinical tests) or to both.
(16) The criteria of quality, safety and efficacy should enable the risk-benefit balance of all veterinary medicinal products to be assessed both when they are placed on the market and at any other time the competent authority deems this appropriate. In this connection, it is necessary to harmonise and adapt the criteria for refusal, suspension and revocation of marketing authorisations.
(17) In the veterinary sector, if no medicinal product has been authorised for a given species or a given disorder, the possibility of using other existing products should be made a straightforward matter, but without prejudicing consumer health in the case of medicinal products intended for administration to food-producing animals. In particular, medicinal products should be used only under conditions that guarantee that the foodstuffs produced will be harmless to consumers as regards any residues of medicinal products.
(18) There is also a need to stimulate the interest of the veterinary pharmaceuticals industry in certain market segments in order to encourage the development of new veterinary medicinal products. The period of administrative data-protection vis-a-vis generics should be harmonised.
(19) There is also a need to clarify the obligations of, and division of responsibilities between, the applicant for a marketing authorisation, the holder of a marketing authorisation and the competent authorities in charge of monitoring the quality of foodstuffs, particularly through compliance with the provisions on the use of veterinary medicinal products. In addition, in order to facilitate the testing of new medicinal products while guaranteeing a high level of protection for consumers, sufficiently long withdrawal periods should be laid down for foodstuffs that animals involved in tests might produce.
(20) Without prejudice to the provisions aimed at guaranteeing consumer protection, the specific characteristics of homeopathic veterinary medicinal products, and particularly their use in organic farming, should be taken into account by establishing a simplified procedure for registration on terms defined in advance.
(21) In order to increase the information available to users and to improve consumer protection in the case of food-producing animals, the provisions on the labelling of veterinary medicinal products and the accompanying package leaflet should be strengthened. The requirement that a veterinary medicinal product may only be dispensed after a veterinary prescription has been made out should, as a general principle, be extended to all medicinal products for food-producing animals. However, it should be possible to grant exemptions, where appropriate. The administrative procedures for supplying medicinal products for pets, on the other hand, should be simplified.
(22) The quality of veterinary medicinal products manufactured or available in the Community should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice. It has proved necessary to reinforce the Community provisions on inspections and to compile a Community register of the results of those inspections. The provisions for the official release of batches of immunological medicinal products should be reviewed in order to take account of the improvement of the general system for monitoring the quality of medicinal products and to reflect technical and scientific progress, and also in order to make mutual recognition fully effective.
(23) The environmental impact should be studied and consideration should be given on a case-by-case basis to specific provisions seeking to limit it.
(24) Pharmacovigilance and, more generally, market surveillance and sanctions in the event of failure to comply with the provisions should be stepped up. In the field of pharmacovigilance, account should be taken of the facilities offered by new information technologies to improve exchanges between Member States.
(25) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(6).
(26) Directive 2001/82/EC should be amended accordingly.