“THE GUIDELINES FOR ISSUING PHARMACEUTICAL PRODUCT CERTIFICATE, FREE SALE CERTIFICATE AND PHARMACEUTICAL PRODUCT MARKETING AUTHORISATION STATUS STATEMENT DOCUMENTS” WAS PUBLISHED WITH THE MDMA’S ANNOUNCEMENT OF JANUARY 11, 2022.
The purpose of the Guidelines is to regulate the application conditions, documents, certificate, declaration, and naming commitment samples required for the issuance of "Pharmaceutical Product Certificate", "Free Sale Certificate" and "Pharmaceutical Product Marketing Authorisation Status Statement".
The Guidelines cover medicinal products for human use, traditional herbal medicinal products, foods for special medical purposes and homeopathic medicinal products as well as the natural and legal persons who have applied for a license and/or been granted a license/permit.
The said Guidelines enter into force on February 1, 2022 and can be accessed via: