Explanatory Memorandum to COM(2001)404-3 - Amendment of Directive 2001/82/EC on the EC code relating to veterinary medicinal products - Main contents
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| dossier | COM(2001)404-3 - Amendment of Directive 2001/82/EC on the EC code relating to veterinary medicinal products. |
|---|---|
| source | COM(2001)404  |
| date | 26-11-2001 |
The Community provisions on the marketing of veterinary medicinal products are, for the most part, similar or identical to those concerning products for human medicine. No veterinary medicinal product may be marketed unless its quality, safety and efficacy have been demonstrated, and unless these guarantees are maintained when the product is actually placed on the market.
The veterinary sector nevertheless has a number of specific features.
First, it should be borne in mind that veterinary medicinal products for food-producing animals may be authorised only on terms that guarantee that the food will not be harmful for the consumer. The provisions governing the use of such medicinal products by practitioners and farmers notwithstanding, manufacturers must from the outset provide all the necessary information on residues of these products that may remain in items produced from animals that have been treated.
Second, the availability of certain medicinal products is a growing problem.
Thus, the animals that are to benefit from treatment - particularly farm animals - have a limited economic value, while all the costs of treatment or prevention must be borne by the owner. In addition, certain markets are restricted because of the number of species concerned, the size of the animal populations, the range of disorders, or differences in the regional situations.
Contents
- II. Justification
- B. Legal basis and procedure
- III. Detailed contents of the proposal
- A. Definitions, scope, general terminology
- B. Marketing authorisations: general provisions and procedures
- C. Marketing authorisations: proposals specific to the veterinary sector
- E. Labelling and package leaflet
- F. Possession, distribution and dispensing
- G. Pharmacovigilance
A. Aims
1. In the light of experience with the operation of Community marketing procedures for medicinal products and the conclusions of the Commission report to the European Parliament and the Council (COM(2001)...), the Commission saw a need to adapt certain provisions of Regulation (EEC) No 2309/93 i 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 (COM(2001) 404 final, European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products for human use i, and European Parliament and Council Directive 2001/82/EC on the Community code relating to veterinary medicinal products i. The revision of the latter is the subject of this proposal for amendments.
2. In so far as the general aims and the provisions on the authorisation and use of medicinal products in the Community are comparable in both the human and the animal health sectors - particularly as regards ensuring quality, safety and efficacy -this parallel approach should be maintained as far as possible, as regards both the general terminology and the system for assessing the quality, safety and efficacy of medicinal products as the basis for granting marketing authorisations. This also applies to the constant monitoring of the quality of the medicinal products manufactured by means of a quality-assurance system, a code of good manufacturing practice or inspections, and subsequent monitoring of the safety and efficacy of the products by means of a pharmacovigilance system.
The conclusions of the abovementioned Commission report and the reasons underlying the other proposals for revising pharmaceutical legislation are therefore directly applicable to these proposals for amendments in so far as they do not specifically concern veterinary products.
The recent adoption of the two Community codes relating to medicinal products for human and veterinary use also provides an excellent opportunity for improving and simplifying the general legislative framework and, where appropriate, amplifying or fine-tuning certain provisions on veterinary medicinal products to bring them into line with provisions that already exist for medical products for human use or proposed amendments to those provisions.
3. This proposal also is also intended to take account of the specific problem of the availability of veterinary medicinal products, as envisaged by the Commission in its Communication to the European Parliament and the Council of December 2000 i. The general aim is to adapt the regulatory framework to the specific features of the animal health sector in order to curtail or reverse the downward trend in the number of veterinary medicinal products available. There is a need, therefore, for a balanced response to the imperatives of animal health and well-being, particularly where food-producing animals are concerned, without prejudice to a high level of protection of the health of the final consumer.
4. Finally, outside the scope of this proposal, the Commission is continuing its reflections on the possibility of developing in parallel a policy analogous to the 'orphan drugs for human use' scheme for veterinary medicinal products, by means of a specific legal instrument. The paths to be explored should seek in particular to define indirect incentives to promote the development of new veterinary medicinal products specific to these abandoned market segments (reduced registration fees, technical assistance from the Agency, longer exclusive market rights, and others). Direct incentives could also be considered (financial contributions to R&D, reimbursement of certain investments on granting of marketing authorisation, voluntary co-financing by associations of breeders of the species concerned, etc.) But the Commission considers that if such a proposal should see the light of day, the scope and the ways and means of its application will need to be precisely identified.
The legal basis for the proposal is Article 95 and Article 152.4(b) of the Treaty. Article 95, which specifically prescribes use of the co-decision procedure described in Article 251, is the legal basis for achieving the aims set out in Article 14 of the Treaty, which include the free movement of goods - in this case veterinary medicinal products. While taking account of the fact that any regulations on the manufacture and distribution of medicinal products, including veterinary medicinal products, must be fundamentally aimed at safeguarding public health, this aim must be achieved by means that do not impede the manufacture and free movement of medicinal products within Community. Since the Amsterdam Treaty came into force, all legislative provisions adopted by the European Parliament and the Council - except for directives adopted on the basis of executive powers vested in the Commission - and aimed at aligning the provisions on medicinal products have been adopted on the basis of that Article, since the differences between the national legislative, regulatory and administrative provisions on medicinal products tend to hinder intra-Community trade and therefore directly affect the operation of the internal market. The intervention of the Community legislator is therefore justified with a view to preventing or eliminating these obstacles. Furthermore, Article 152.4(b) mentions henceforth explicitly the measures having as direct objective public heath protection in the veterinary and phytosanitary sectors. The present proposal contains a number of measures in the veterinary field having as an objective public heath protection. The adoption procedure referred to in this Article is the same as the one referred to in Article 95; thus, it is wise to add this Article as a legal basis.
(To improve readability, the Articles quoted here are those contained in Directive 2001/82/EC as amended by this proposal).
1. It is proposed that use of the term 'proprietary medicinal product' [spécialité pharmaceutique] be discontinued, since it is no longer used in the legislative provisions and there have been difficulties in defining precisely how it should be interpreted. Use of the term 'Ready-made veterinary medicinal product' [médicament vétérinaire préfabriqué], defined by reference to 'proprietary medicinal product', has therefore also been discontinued (Article 1).
It is proposed that the scope of the directive should be clarified and in particular that it should be specified that the granting of a marketing authorisation or any directly associated arrangement is relevant only once a medicinal product has begun to be manufactured industrially (Article 2(1)). Nevertheless, it should be made clear that, for reasons of both animal and public health, officinal or magistral veterinary preparations made up in a pharmacy should be subject to the provisions of the directive regarding prescription, dispensing, possession and administration to animals (Article 3(1)).
2. The definition of a veterinary medicinal product has been adapted in order to ensure that the directive applies to certain products that must meet the requirements of quality, safety and efficacy. This adaptation only makes it possible not to extend the concept of medicinal product to new types of treatment, such a cell therapy, but also to clarify the status of certain more traditional products, such as those used for extracorporeal dialysis, even if these products are not at present of comparable importance in both veterinary and human medicine.
3. The additions to the definitions of the terms 'adverse reaction', and the inclusion of new definitions (Article 1), particularly of 'veterinary prescription', 'name of medicinal product', 'non-proprietary name', 'strength', 'immediate packaging', 'outer packaging', 'labelling' or 'package leaflet' are in line with the definitions for medicinal products for human use.
The definition 'withdrawal period' has also been revised in order to highlight its principal purpose, i.e. protecting the public, when used correctly in a veterinary context (Article 1).
4. The possible dual use of certain products - as a pharmaceutical product or veterinary hygiene product, for example - has led to differences in interpretation and the adoption of different regulatory approaches in the various Member States. It proposed, therefore, that in such circumstances the legislation affording the highest degree of protection for animal and human health, i.e. that covering veterinary medicinal products, should apply in cases of uncertainty (Article 2(2)).
5. Finally, this proposed revision provides an opportunity to harmonise and simplify, and to correct certain terminology that is regarded as obsolete or inappropriate for the field. It mainly concerns references to the evaluation criteria - i.e. quality, safety and efficacy - or introducing the idea of weighing benefits against risks, which is central to the system of marketing authorisation for medicinal products.
1. The general provisions on applying for a marketing authorisation, assessing applications, granting marketing authorisation, and the respective responsibilities of the competent authorities and the holder of the authorisation do not depend on the type medicinal product in question - i.e. whether it is for veterinary or human use. The justification and proposed amendments are therefore complementary to those relating to Regulation (EEC) No 2309/93 (COM(2000)...), or similar, if not strictly identical, to those relating to the legislation on medicinal products for human use (COM(2001)...).
2. The same is true of the general provisions on the scope of the authorisation and the responsibility of the holder (Article 5), and the additional details on the concept of generics and Community harmonisation (ten years) of the period of administrative protection of data (Article 13 i, i and (3)), 'bibliographical applications' (Article 13a), fixed combinations (Article 13b), or applications submitted with the consent of the holder (Article 13c). The amendments also introduce the possibility of testing a generic before the end of the period of exclusivity without thereby infringing the law on the protection of industrial and commercial property (Article 13(6)).
3. Similarly, Chapters 3 and 4 of Title III, on the marketing-authorisation procedure and the mutual-recognition or decentralised authorisation procedures have been adapted in exactly the same way as the corresponding chapters of the Community code relating to medicinal products for human use. Particular attention should be draw to the proposals concerning the coordination of deadlines for the various procedures (Articles 21 and 32), authorisation on specific conditions (Article 26), the discontinuation of the five-yearly renewal of the authorisation and the expiry clauses (Article 28), or the transparency of the assessment process (Article 25 i and (4)). For the decentralised procedure, it is proposed to set up a coordination group on the mutual recognition of veterinary medicinal products, thus formalising an existing process of cooperation between the Member States (Article 31), to clarify operation on the basis of whether or not an authorisation already exists in a Member State (Article 32), and to make the initiation of the arbitration procedure automatic in all cases of dispute between the competent authorities in the Member States (Article 33). The provisions on arbitration have been clarified, particularly with a view to protecting the position of the applicant or the marketing authorisation holder more effectively (Article 36). It is also proposed to speed up certain stages in the procedure for obtaining the opinion of the committee and completing the decision-making process (Article 38), and it is intended to establish a system for the gradual harmonisation of summaries of characteristics of products for veterinary medicinal products that have been authorised by the Member States for more than ten years (Article 34(2)), and to introduce the possibility of the Agency giving an opinion on certain parts of the marketing authorisation if the question at issue concerns more than one product or a therapeutic class (Article 35(2)).
4. It is also proposed to adapt, while taking account of the specific features of veterinary medicinal products, certain provisions regarding the contents of the file accompanying an application for marketing authorisation and the summary of product characteristics (Articles 12, 14, 15). These adaptations will not change the essence of the existing provisions, but will be more concerned with gearing certain provisions with sometimes outdated wording to the administrative, scientific or technical realities of the applications. Thus, the erstwhile 'expert reports' will continue to exist, but under the name 'detailed and critical summaries', particularly in so far as most of the scientists involved in drafting the reports will be associated to a greater or lesser extent with the applicant. It is also proposed that it should be clearly stated that these summaries form an integral part of the application file. Withdrawal periods are also indicated in the interests of improved protection for the final consumer (Article 14(5.11)).
1. Obviously, the general principle of authorising the marketing of a veterinary medicinal product before it can be used is not being questioned.
Nevertheless, a number of adjustments have been proposed to permit derogations from the authorisation requirement, either for certain 'new' categories of pets, such as dwarf rabbits or ferrets (Article 4(2)), or for the use of a medicinal product on animals subject to compulsory specific health provisions with a view to export to non-member countries or import into the Community. This proposal particularly concerns certain sport animals taking part in international competitions (e.g. horses), or certain valuable productive livestock, which must be vaccinated against infectious diseases that are endemic in certain non-member countries (Article 8(2)). The directive has also been brought into line with other Community provisions in order to enable the Commission to permit the use of immunological veterinary medicinal products without a marketing authorisation in cases of serious epizootic diseases if no suitable medicinal products are available (Article 8(1)). This provision also contributes to improving the consistency of Community measures to combat certain animal diseases, and particularly concerns alignment with the Commission's proposal for amending Regulation (EEC) No 2309/93 in order to permit authorisation through a centralised procedure for immunological veterinary medicinal products for such diseases. It has also been found necessary to introduce derogations from the need to conduct field trials for these medicinal products (Article 13d).
2. If no authorised medicinal product is available for a given species or disorder, it is proposed that the use of other products be made more straightforward. The aim is to help solve the problem of the availability of certain veterinary medicinal products and the intention is to differentiate the provisions regarding pets or animals kept in zoos or circuses (Article 10) more clearly from those on food-producing animals (Article 11).
In the former case, it is intended to retain the system whereby either another veterinary medicinal product, a medicinal product for human use, or a product prepared extemporaneously must be used in that order of priority ("cascade"). However, this possibility will henceforth be open directly to practitioners on their own direct responsibility. It is also proposed to eliminate all associated administrative formalities - particularly the recording of the use of such products - in so far as such provisions do not affect the level of consumer protection.
In the case of food-producing animals, it proposed to keep veterinary practice under administrative supervision, thus enabling the Member States to opt for the use of a veterinary medicinal product authorised in another Member State. This provision must be supplemented by ad hoc import and inspection measures. The measures aimed at protecting consumers have been retained (withdrawal period, registration of use) and clarified (inclusion of the substance in Annex I, II or III to Regulation (EEC) No 2377/90, existence of maximum residue limits for at least one species).
Regarding horses, given the specific ways in which those are used, It is proposed to allow the use of a substance which does not have any maximal residue limit, under the only condition that the animal in question is excluded from the nutritional chain (Article 10 (2)). This implies that many of these are treated in a way comparable to company animals, and this in an unalterable way. The definition of an arbitrary six-month waiting period, provided for in the Commission Decision 2000/68/EC concerning the passport of horses i, could only be justified under limited and exceptional circumstances. The Commission considers that such a possibility should not become the general rule in the Community, not only in order to take into consideration the direct protection of European citizens consuming horse meat, but also in order to ensure the general coherence of consumer protection measures within the framework of the use of veterinary medicinal products on all animal species. The equidae remain as such food producing species at European level.
3. In addition to the measures concerning the use of products without authorisation for the species or indication concerned, it is also proposed that economic incentives be introduced to encourage the pharmaceutical industry to place veterinary medicinal products on the market without delay.
The main amendment is a proposal to increase the period of administrative data protection in some cases and hence provide for a more attractive return on investment for an economic operator (Article 13 i and (5)):
- The ten-year protection period would be extended by one year for any extension of the authorisation to another food-producing animal (up to a maximum of three more years for three or more species), provided that such an extension is obtained within three years of the granting of the original authorisation. A measure of this kind would encourage the industry to extend the authorisation of a new medicinal product for a species representing a major economic sector very swiftly to other species representing a smaller market.
- It is also proposed that the period of general protection for medicinal products for bees and fish should be 13 years instead of 10, because of the specific characteristics of these species and the general veterinary treatment procedures that necessitate specific developments on the part of manufacturers.
It is also proposed that the protection should at the same time cover the data contained in the file submitted for the establishment of maximum residue limits as required under Regulation (EEC) No 2377/90 and in the application for authorisation (Article 13(a) i and (2)), and to strengthen the legal links between the procedures for fixing maximum residue limits and the granting of a marketing authorisation (Article 6, Article 12(1)). It is also intended to grant a period of three years of specific protection for a medicinal product containing of substance of which use has been well established in a species for not less than ten years, but for which the marketing authorisation has been obtained for a 'new' species by a holder other than the holder of the original authorisation. This protection would, however, be granted only if the new holder had also been the applicant for the establishment of maximum residue limits for the new species and had provided the evidence of the efficacy of the medicinal product in this new species (Article 13(a)(3)).
4. In view of the problem of availability of veterinary medicinal products and in particular the difficulties encountered by manufacturers (see the abovementioned Commission report COM (2001)...), it is proposed that the obligations and the division of responsibilities between the applicant for or the marketing authorisation holder for a veterinary medicinal product and the competent authorities in the Member States should be clarified. This mainly concerns the implementation of general checks of the quality of foodstuffs and the residues of chemical substances in connection with the misuse of authorised medicinal products, the use of prohibited substances, or contamination of foodstuffs by pollutants.
Scientific studies to back up a file of maximum residue limits or a file of a marketing authorisation will mean that the applicants will have to develop methods for determining the concentration of active substances and any active metabolites in certain tissues or types of foodstuff of animal origin. Nevertheless, the aims of studies of this kind and the experimental conditions under which they are conducted are not the same as those of the control laboratories responsible for monitoring any residues of chemicals that might be present in foodstuffs in general. Consequently, the control laboratories will as a rule need to develop their own methods.There is a need to review the provisions on the analytical methods to be used to determine the amounts of residues, particularly as the expression 'routine analysis method' has given rise to many questions of interpretation (Article 12(3)(h), (i), and (j). The obligation of the applicant to demonstrate the quality and reliability of the scientific information presented in his/her file and to provide a validated dosage method has not been changed. This provision has even been strengthened by the introduction of the possibility of checking whether the method is satisfactory in the light of the aims of the application (Article 23(3)). It is also proposed that the provisions on the monitoring of residues should be strengthened and in particular that the task of the competent authorities should be simplified if specific needs are involved. The marketing authorisation holder should therefore, on request by the competent authorities, supply the reference substances needed for the control. It is also intended that the authorisation-holder should provide the reference laboratory with technical support if it has to use the analytical method described in the authorisation file but encounters practical difficulties (Article 27(2)).
5. It is also intended to revise the general provision on total exclusion from human consumption of foodstuffs from animals used for testing medicinal products if maximum residues limits have not been established in accordance with Regulation (EEC) No 2377/90, since this provision is a major obstacle to the development of new medicinal products for food-producing animals. The existing provision impedes the development of a new veterinary medicinal product for several years - even to the point of discouraging pharmaceutical companies from developing innovative medicinal products for major markets.
The example of new medicinal products for dairy cows may serve as an illustration: unless it carries out trials outside the Community, it becomes extremely difficult for a pharmaceutical company and the experts responsible for conducting field trials to find a farmer who will agree to having an animal from his/her herd included in a clinical study of a new veterinary medicinal product if this means that it will not be possible to use the animal for milk production again.
The number of productive livestock used in testing veterinary medicinal products is small compared with the number of animals likely to be treated with a medicinal product outside the authorised use, if only because of the 'cascade' provisions described in C.2). Testing of new medicinal products also necessitates close veterinary observation of the animals and major monitoring work on the part of the person responsible for the test. These measures do not compare with the normal conditions of use of an authorised medicinal product in productive livestock. The Commission therefore considers that consumer protection would not be affected in these particular circumstances by abolishing the obligation for the prior establishment of maximum residue limits, since this measure is accompanied by the introduction of a sufficiently long withdrawal period (Article 95).
6. It is proposed that the provisions on homeopathic veterinary medicinal products should be adapted to the current situation. Since no use has been made of the possibility for a Member State to refrain from establishing a simplified registration system for homeopathic medicinal products meeting certain criteria, it is proposed that it should be abolished (Article 16).
Also, particularly in view of the developments in biological agriculture and the special place of homeopathic medicinal products in that context, it is proposed that the simplified registration system should be extended to veterinary medicinal products intended for food-producing species. This does not, however, affect the provisions on consumer protection (Article 17 i, Article 18). It is also proposed, under certain conditions, to authorise the Commission, if appropriate, to adapt the degree of dilution in the light of new scientific knowledge (Article 17(1)). It is necessary, therefore, to adapt the provisions on labelling and the package leaflet accompanying homeopathic veterinary medicinal products (Article 64).
D. Provisions aimed at improving the monitoring of the quality of medicinal products.
1. Monitoring the general quality of medicinal products depends partly on the system of granting marketing authorisations on the basis of a prior assessment of the information submitted by the applicant, including all pharmaceutical documentation. It also depends on constant subsequent monitoring of the quality of the products manufactured and sold, and their conformity with the specifications laid down in the authorisation.
Quality guarantees are based essentially on a system of quality assurance, including compliance with good manufacturing practice, and monitoring of conformity with all the provisions by the competent authorities - mainly by means of inspections. These general measures are applicable to both medicinal products for human use and veterinary medicinal products.
2. The Commission must therefore pursue the same objectives in the field of veterinary medicinal products and propose similar amendments to those made to the legislation on medicinal products for human use (COM(2000)...). However, account must be taken not only of consumer protection and the completion of the internal market, but also of the international dimension of the pharmaceutical sector (particularly mutual recognition agreements with third countries).
3. The Commission therefore finds it necessary, at this stage, to strengthen the provisions on inspection, in conjunction with the European Pharmacopoeia where appropriate (Article 80 i and (4)), to step up Community coordination by introducing certificates of good manufacturing practice, and to set up a Community register containing the relevant information (Article 80 i, i and (7)). The latter measure is in a consistent manner supplemented by the establishment of Community system of data on manufacturing authorisations (Article 44(4)). All this is also intended to facilitate mutual recognition within the system. It is proposed, however, to introduce a procedure for settling any disputes concerning the outcome of an inspection (Article 90). This improvement of Community harmonisation goes hand-in-hand with a total harmonisation of the criteria to be met by the qualified person responsible for the quality of manufacturing (Articles 53 and 54).
It is also intended to increase the quality guarantees by extending good manufacturing practice (Article 50(f)) to the starting materials used as active substances in veterinary medicinal products. This means that this term must be clearly defined and that there must be procedures for revising the definition in the light of technical progress (Article 50a). The practical provisions have been adapted accordingly, both for the adoption of specific detailed guidelines (Article 51) and for the inspection system (Article 80(1)). It also appears necessary to clarify the provisions on monitoring the quality of imported products, since even if they had originally been manufactured in the Community, the competent authorities will not be able to ensure that all the specifications, particularly those concerning storage conditions for medicinal products, have been respected outside the Community (Article 55).
4. In the field of immunological veterinary medicinal products, the existing legislation stipulates that the Community provisions on quality assurance in connection with manufacturing authorisations, good manufacturing practice and inspections may be supplemented by a system of 'official release' of each batch of the product after manufacture, after control by an 'official' laboratory designated for this purpose by the competent authorities of the Member State. In these circumstances, the 'official batch release' of a batch of vaccine would have to be the subject of mutual recognition.
Since this measure was introduced at Community level (1990), along the lines of long-established practices in some Member States, significant progress has been made in quality and consistency in the manufacturing of vaccines. Furthermore, in view of the number and diversity of immunological products in the veterinary sector, the national laboratories do not necessarily have the means for re-control of the batches that have already been checked by the manufacturers, and only some Member States use the 'official release' procedure. Finally, the system of mutual recognition does not operate ideally, mainly because the Member States do not necessarily carry out all the conformity controls provided for in the authorisation file - hence the discrepancies in the Community-level validity of the 'official release'.
The Commission therefore proposes reviewing this arrangement, partly by restricting the scope for official release of batches to certain types of immunological veterinary medicinal products, i.e. live vaccines or immunological medicinal products for diseases covered by Community measures, which would mean particular responsibility for the competent authorities. It is also proposed to define the obligations on pharmaceutical companies and the competent authorities under these circumstances, particularly as regards the tests that need to be done by official control laboratories (Article 82). These proposed amendments are without prejudice to the possibility of requiring copies of any certificates describing the controls conducted by the holder, or to having medicinal products placed on the market controlled by the official laboratory at any time.
The provisions on labelling of medicinal products and the accompanying package leaflet have not been amended substantially. The terminological improvements in connection with the introduction of the new definitions notwithstanding, it is proposed that certain provisions aimed at improving information for users should be strengthened.
The labelling and the package leaflet must be approved by the competent authorities and conform to the summary of the characteristics of the product (Article 58 i, Article 61(2)). The labelling of veterinary medicinal product and the accompanying package leaflet consequently also become important elements in the application for a marketing authorisation and the decision taken by the competent authorities (Article 25 i, Article 30(e), Article 32 i, i, i and i, Article 33 i, Article 36).
A number of amendments have also been proposed in the general interests of users (Article 58(1)(e); Article 61 i and (2)(a) and (b) while taking account of certain elements of flexibility, including some for medicinal products that are covered by a centralised marketing authorisation under Regulation (EEC) No 2309/93 (Article 58(5)).
It is also proposed that the information on use in food-producing animals - in this case, the withdrawal period (Article 58(1)(g) and (l) should be strengthened. This goes hand-in-hand with a proposal to strengthen the measures relating to the prescription procedures for medicinal products of this kind (Article 67). It is proposed that in future all medicinal products for food-producing animals (including, for example, those for which the withdrawal period is nil) should be available only on veterinary prescription.
In addition to the abovementioned provision on the prescribing of medicinal products for food-producing animals, it is proposed that the provisions on emergency recall of medicinal products from the market should be amplified, as the case may be by including wholesale distributors (Article 65(4)).
Even if the provisions on the traceability of the distribution circuits for veterinary medicinal products from the manufacturer to the final user have not been amended - indeed they have been strengthened by the fact that the range of prescription-only medicinal products has been extended. It is, however, proposed that retail sale should be simplified for those for which no prescription is required, by abolishing the obligation to keep detailed documentation (Article 66(2)).
The special conditions on a possible ban on manufacturing, possessing or selling certain immunological veterinary medicinal products are extended to the marketing authorisation according to a decentralised procedure (Article 71 i, in conjunction with Article 33 i second subparagraph), in order to take account of the proposal for 'automatic' initiation of the arbitration procedure.
The pharmacovigilance procedures have been strengthened (Articles 72-78) along the lines of the proposals in connection with the centralised procedure and more generally those on medicinal products for human use, particularly in conjunction with the proposal to abolish the five-yearly renewal of the authorisation. It is intended to strengthen the general information network, particularly by electronic means and to increase the frequency with which the periodical safety update reports are to be submitted. One of the aims is to enable the Commission to ask the Member States to take temporary measures with immediate effect, if emergency action is needed.