Parallel to the harmonisation process of Turkish legislation with European Union law, the legal environment regarding veterinary products is also evolving in Turkey. The initial change started in 2010 with the Law on Veterinary Services, Plant Health, Food and Feed with No. 5996 which was published on the Official Gazette dated 13.06.2010. Then in 2011, the Ministry of Food, Agriculture and Animal Health ("MoA") was subject to an internal restructuring process whereby the Veterinary Products and Public Health Department was established under the authority of MoA to deal with the veterinary products. Recently, based on the powers granted in Law No. 5996, the Ministry issued the Regulation on Veterinary Medicinal Products ("New Regulation") on the December 24, 2011, which introduced new changes and abolished previous regulations on veterinary products. Pursuant to Article 3/b, the New Regulation corresponds with the EU Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001 on the Community Code Relating to Veterinary Medicinal Products.
With the New Regulation, even though the main philosophy remains the same; some important changes have been introduced as well as some terminology changes. Overall, the changes reflect the general legal position of the human medicine products legislation, thus it can be stated that the purpose of the legislation was to create a similar approach for both human medicinal products and veterinary products.
In this article, rather than referring to the nonchanged issues, we have provided an overview on newly introduced issues of the New Regulation respectively "Good Manufacturing Practice, Promotion Rules, Retail and Wholesale of Veterinary Products, Pharmacovigilance and finally Sanctions".
1. Good Manufacturing Practice ("GMP") Requirements
The GMP certificate requirement is a well-established practice in human medicine legislation, despite the critics and debates due to the new requirements introduced for imported human medicine products in 2010.
As for veterinary products, until the New Regulation a GMP certificate was not required for the registration of the products, although in practice, importers must have GMP certificates to complete the customs clearance for imported veterinary products. Now the New Regulation requires GMP certificates for both domestic and imported veterinary products. For domestic products, the MoA shall have the authority to check the manufacturing facility and provide the GMP certificate; whereas for imported products the GMP certificate is to be approved by the competent authority of the origin country.
The New Regulation prohibits the manufacturing facility, approved by the MoA to manufacture any other products. Pursuant to Article 21, all veterinary products, except veterinary biological products, can also be manufactured alongside human medicine products, in facilities approved by the Ministry of Health.
Similar to the GMP requirements for manufacturing facilities of human medicine products, a responsible manufacturing facility manager as well as quality control and quality assurance manager must be employed in the manufacturing facilities for the veterinary products.
Despite the detailed provisions in the New Regulation, the MoA is expected to issue a Guide for manufacturing of veterinary products within one year of the New Regulation as set forth in Article 87. To our best knowledge, the MoA has already sent the Draft Guide to the players in the veterinary products sector to obtain feedback of the sector and is resolved to issue the Guide by the first anniversary of the New Regulation.
Before the New Regulation, the promotion of the veterinary products to the public was not restricted and for the first time promotion activities have been formally regulated under the New Regulation. Briefly, the New Regulation reflects the similar approach of the Regulation on Promotion Activities of Medicinal Human Products.
The New Regulation only allows the promotion of veterinary products to the veterinarians and pharmacists; and promotion to the public is prohibited. Furthermore, any type of advertising via radio, television, internet, magazine etc. is prohibited; however, the registration holders are allowed to announce, for once, the launch of the product to the market with the prior approval of the MoA. The prohibition for promotion and advertisement is not only brought for registration holders, but also for wholesalers and pharmacies or any other veterinary product sellers.
Pursuant to the New Regulation, samples can only be provided within two years following the launch of the products and shall be limited with %5 of the previous year's sales.
The remaining provisions regarding the promotion lay down the rules concerning general principles of promotion, promotion materials and relations with the sales and medical representatives.
Before the New Regulation, except the global companies who are required by their own internal global rules to stick to some ethical standards, the local companies were not required to apply ethical rules in promotion of veterinary products. On the other hand, the New Regulation requires the MoA to control the types of promotion in order to avoid unethical and/or misleading promotion.
3. Retail and Wholesale of Veterinary Products
Unlike the previous regulation, the New Regulation adopts "Veterinary Product Wholesalers" operating under the responsibility of a veterinarian or pharmacist and a similar system to human medicine was brought whereby veterinary product wholesalers have become a mandatory stop for sale.
Pursuant to the New Regulation, the wholesale of veterinary products can only be made by the veterinary product wholesalers and human medicine wholesalers, which are to be approved by Ministry of Health. On the other hand, the retail sales are to be conducted by the pharmacies or the clinics, and animal hospitals approved by the MoA. In addition, it is clearly regulated that the wholesalers are not allowed to directly sell the products to the end users. With this approach, the New Regulation clearly indicates the supply chain of the veterinary products from the registration holder to the end user.
The New Regulation also introduces a pharmacovigilance requirement. As with human medicine products, the New Regulation provides details on pharmacovigilance aimed at research, to evaluate the effects and/or adverse effects of veterinary products that occur at normal doses and requires registration holders as well as the veterinarian to make safety notifications to the MoA. The New Regulation further provides that a veterinary surgeon should be appointed as a pharmacovigilance manager of the registration holder. Along with the GMP requirement, the MoA should also issue a Guide for pharmacovigilance within one year of the New Regulation.
It is worth mentioning that global companies have already maintained a pharmacovigilance system due to their internal standards. Therefore, implementing the new pharmacovigilance requirements may not be a burden on companies; however, they must implement and familiarise with pharmacovigilance system as soon as possible.
Unlike the previous regulation, the New Regulation sets forth sanctions such as suspension and cancellation of the product registrations and sanctions in case of non-compliance to the provisions regarding promotion and pharmacovigilance, etc. Last of all, the Regulation also provides detailed provisions regarding audit of manufacturing facilities and wholesalers and the relevant sanctions to be applied to the same in case of non-compliance.
As mentioned at the beginning, this New Regulation is one of the yields of the harmonization process with the EU and it has been an important step forward for Turkey to address contemporary standards of veterinary products. Furthermore, with the issuance of detailed secondary legislations and guides which are expected to be implemented very soon we foresee that Turkey may reach the needed standards for veterinary products legislation. Last of all, the industry's adaptation to the new legislation is a question mark especially for the local companies. Since even before the New Regulation most of the multinational companies have already implemented and applied its global policies in the Turkish market, the main concern for the adaptation is generally towards the local companies which used to make use of the non-restricting nature of the previous legislation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.