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The European Union has combined in a single act all current legal provisions on production, marketing, distribution and use of veterinary medicinal products. In 2004 this legislation was amended to take account, in particular, of experience gained and the rapid development of knowledge and technology in the area of pharmaceuticals. 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.
The code will apply to all veterinary medicinal products, with the exception of:
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 "officinal" formula;
medicinal products based on radioactive isotopes;
certain additives incorporated into animal feedingstuffs.
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 (EEC) No 2377/90 (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.
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 months 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, preâ€‘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.
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.).
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.
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.
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;
officinal 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.