Data exclusivity, a key IP concern for research-based pharmaceutical companies, was introduced into the Turkish legislation with the publication of the Regulation on Marketing Authorization for Medicinal Products for Human Use in January 2005. The regulation only relates to pharmaceuticals for human use and does not bring exclusivity on the test data relating to agricultural chemicals, such as pesticides or insecticide, to obtain authorization for marketing in the country.
The Turkish data exclusivity law provides six-year market exclusivity for pharmaceutical products obtaining marketing authorization and prevents any production or marketing of generic pharmaceutical products with a similar formula during the same period. The exclusivity period begins from the date on which the marketing authorization is first granted in any member states bounded by EU Customs Union.
The data exclusivity does not allow and award any extended protection for patented pharmaceutical products, which means that under any condition, the exclusivity for pharmaceutical products having a patent grant is limited to the lifetime of the patent.
Original medicinal products which have obtained marketing authorization since January 1 2001 are kept under the scope of data exclusivity and generics can only be registered in exceptional cases affecting seriously the general public health. On the other hand, generic medicinal product applications filed up to January 1 2005 are permitted to remain valid along with the original medicinal products.
The Directorate of Pharmaceuticals and Pharmacy is the competent authority for executing the marketing approvals for data exclusivity. For this purpose, the applicant must submit to the Authority general information such as its title, address, the product name, production method, the features of the product in daily terminology, dosage, therapeutically inductions, contra- inductions, adverse effects, pharmaceutical form, administration method and way, life in shelf, packaging, storage conditions, the description of control methods, tests and the results of toxicological, pharmacologic and clinical searches.
In seeking the data exclusivity, the applicant is not bound by presenting the results of the toxicological and pharmaceutical tests and the clinical trials on the condition of proving that (1) medicinal products are mostly similar to the pre-authorized medicinal product in Turkey and there is the consent of the authorized owner of the original medicinal product to the use of toxicological, pharmaceutical and/or clinical references for the original product in examination of the relevant application and (2) medicinal products fundamentally similar to a medicinal product that has been authorized in accordance with current regulations whose term of data exclusivity has expired.
 |
| Oktay Simsek |
Destek Patent Inc
Tophane Orta Pazar Cad. No.7
Bursa 16040
Turkey
Tel: +90 224 2249194
Fax: +90 224 2221686
destek@destekpatent.com
www.destekpatent.com
