Veterinary product registration, requirement

The VICH is a trilateral (EU-Japan-USA) program, initiated in 1983, whose mission is the harmonizing of technical requirements for veterinary product registration. The objectives of the VICH are along the same lines as those of the ICH which include ... 

In 1996, the VICH program was officially launched among the European Union, Japan, and the United States (52). Among the objectives of the VICH is to provide a forum for a constructive dialogue between regulatory authorities and the veterinary medicinal products industry on the real and perceived differences in the technical requirements for product registration in die three jurisdictions, with tlie expectation that such a process may serve as a catalyst for a wider international harmonization. VICH should identify areas in which modifications... 

For this reason vaccine formulation tends to follow the traditional routes innovative formulations are rare. Aluminium hydroxide, aluminium phosphate and calcium phosphate are still the only registered vaccine adjuvants for humans. Veterinary vaccines have to rely on the same components, however, a few vaccines containing a mineral oil adjuvant (Marcol) or saponin (Quil A or derivatives) have passed the registration hurdles. It remains to be seen whether and under which restrictions these adjuvants can be used in the EEC after 1996 (see also below in "Additional requirements for veterinary products"). 

II. Major Registration Requirements for Veterinary Medicinal Products. 

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH)f ... 

Forwading recommendations on practical ways to achieve harmonization in technical requirements affecting registration of veterinary products and to implement these recommendations in the three regions. Once adopted the VICH recommendations should replace corresponding regional requirements. 

This latter operation has now been completed for approximately 90 percent of MAs. PlLs have now been approved for most authorised medicinal products. The holder of the MA is also required to employ a person who is competent to take full responsibility for compliance of the information and publicity with the regulations and for consistency with the data sheets and patient leaflets accepted at (re)registration. This person has to be a registered pharmacist or physician. For veterinary products this can also be a veterinarian. 

It would be wrong to give the impression that the PAT initiative is confined to the FDA. The FDA has increased its collaboration with international health and regulatory partners, including the International Conference on Harmonisation for the Technical Requirements for Registration of Pharmaceuticals (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Veterinary Medicinal Products (VICH). 

The CVM is also an active participant in a new harmonization effort under the auspices of the Office of International Epizooties. This activity is known as the Veterinary International Cooperation on Harmonisation (VICH) (of Technical Requirements for Registration of Veterinary Medicinal Products-EU). 

Table 16 General Registration Documentation and Requirements for "Non-Immunological" Veterinary Medicinal Products in the EEC.

Registration of a medicinal product in Belgium in 1960 was cin administrative formality, consisting of entry into a register . Since 1962, every proprietary medicinal product for human as well as veterinary use submitted for registration has been examined by the Commission for Proprietary Medicinal Products [not to be confused with the European Community (EC) Committee for Proprietary Medici-ncil Products (CPMP)]. In 1964 this examination became a requirement for all medicinal products. 

Validation of Analytical Procedures Definition and Terminology, VICH GLl, International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), Brussels, 1998 (available at http / /WWW. vichsec. org/pdf/gl01 st7. pdf accessed... 

There are several guidelines available for the conduct of studies for safety, quality and efficacy of veterinary medicinal products. As described in Chapter 2, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) has developed a series of guidelines which have been adopted by a number of... 

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