Authorization of VMP's

Before any veterinary medicinal product designed for animal treatment or disease prevention can be placed on the market, it must be assessed and authorised. Marketing authorisation is a lengthy and complex procedure and is ultimately designed to protect animals, the environment and the public from poor quality or unsafe medicines. The objectives of marketing authorisation are to ensure:

• The product is safe for the consumer of food derived from treated animals, the animal itself, those handling the product, and the environment;
• The product is of high quality, does not deteriorate and has the stability to last at least until the expiry date;
• The product‘s efficacy conforms with the claims made on its information leaflet and label.

Marketing autorisation procedures in the Republic of Lithuania are regulated by the amended document – Requirements on manufacture, registration and marketing of veterinary medicinal products in the Republic of Lithuania (OG, 2008, Nr. 128-4912, 2009, Nr. 118-5106) – which implements EU directive 2004/28/EC amending directive 2001/82/EC.

New requirements foresee four types of marketing authorisation procedures in the EU:

• Centralised procedure
• Mutual recognition procedure
• Decentralised procedure
• National procedure

The centralised procedure

This type of procedure leads to a single marketing authorisation, valid throughout the EU. This Centralised procedure is compulsory for medicinal products derived from biotechnology as well as for livestock performance enhancers. It is also available at the request of a company for other innovative products. An approval for a medicinal product intended for use in all EU countries may be obtained by applying to the EMEA (European Agency for the Evaluation of Medicinal Products) in London. Within the EMEA four scientific committees have been established:

• for human medicinal products, the CPMP (Committee for Proprietary Medicinal Products)
• for veterinary medicinal products, the CVMP (Committee for Veterinary Medicinal Products)
• for orphan medicinal products, the COMP (Committee for Orphan Medicinal Products)
• for herbal products, the CHMP (Committee for Herbal Medicinal Products)

These committees prepare an opinion preceeding the formal approval by the Commission. The Member States have one representative in each committee. The assessment work of the application is done by any of the EU countries. When EMEA has received a centralised application for veterinary medicinal product, CVMP appoints a rapporteur/co-rapporteur. On the basis of the opinion from the scientific committees the Commission (or the Council) issues the formal decision to authorise a product in the centralised procedure. The Commission is assisted in the decision-making procedure by a Standing Committee with representatives from each Member State.

Mutual recognition procedure

A company is obliged to use the Decentralised porcedure, also known as the Mutual Recognition Procedure (MRP) if it wishes to sell a veterinary medicinal product in more than one Member State, but not necessarily throughout the EU (some diseases or species are local).

If the product has already been granted a Marketing Authorisation in one or more Member States, then the company can use MRP to have the existing licence „mutually recognised“ in other Member States of its choice. The pharmaceutical company submits their application to the country chosen (named as Reference Member State (RMS)) to carry out the assessment work, which then approves or rejects the application. The other countries (Concerned Member States (CMS)) have to decide within 90 days whether they approve or reject the decision made by the original country. Two groups are working for the facilitation of the Mutual Recognition and Decentralised Procedure: for human medicinal products, the CMD(h) and for veterinary medicinal products, the CMD(v). CMD(v) consist of representatives of all Member States. In case where a Member State cannot recognise the marketing authorisation issued by the RMS, a referral to the CVMP for arbitration may be made through its secretariat at the EMEA. If the objection is valid, the application for mutual recognition is rejected and the company loses its registration in the RMS. If the objection is not considered valid by the CVMP then all CMS must approve and licence the product. Mutual Recognition Procedure has to be completed in 90 days. The fee for expertise and registration differs in every country.

Decentralised procedure

From November 2005 a new „Decentralised Procedure“ is operational. Unlike the MRP, the company must use the Decentralised Procedure for a new product that has no Marketing Authorisation to obtain mutually recognised Marketing Authorisation in several or all Member States. Under this procedure the dossier is sent to one selected national authority – Reference Member State. The Authorities in the other Member States selected by the company receives the identical dossier in parallel. Reference Member State then carries out a scientific assessment and produces a draft Assessment Report (no decision is taken yet). The other Member States receive a copy of the draft Assessment Report as well. They should then „mutually recognise“ the draft decision of the RMS, or reach mutual agreement through discussion. However if Member States have additional concerns and can not reach agreement, the disputed point is passed to the EMEA (CVMP) for the arbitration procedure (see Mutual Recognition Procedure). Decentralised procedure has two phases: national phase (120 days) and mutual recognition phase (90 days). The fee for expertise and registration differs in every country.

National procedure

If a Company wishes to authorise veterinary medicinal product just in one Member State ( e.g., for local disease or species) application for Marketing Authorisation to a National Competent Authority must be submitted. The dossier on which the marketing authorisation is based shall be assessed by national experts on quality, safety and efficacy. According to experts opinion, granting of Marketing Authorisation shall be approved, futher information shall be requested or even refusal of Marketing Authorisation confirmed in the case of negative opinion.