Products Registration Certificates to Reflect the Adopted Changes in State Registration Procedures for Medicinal Products

On September 16, 2016, the Ministry of Health Order № 773 dated 27.07.2016 «On Amendment of the Ministry of Health Order № 358 dated 29.07.2003» came into effect.

Changes adopted by this Order regarding the form and description of registration certificate for medicinal product/medicinal immunobiological product. The registration certificate will be supplemented with additional lines concerning the validity term of this document. These changes should completely reflect existing legislative approaches to medicinal products’ registration in Ukraine.

In particular, it is worth to mention that as of today the term of registration certificate becomes unlimited after the re-registration of medicinal product. Moreover, the registration certificates of medicinal products, procured by international specialized organizations under centralized procurement procedures, are valid within the duration of the law, which implements this initiative. Therefore, upon the results of state registration of medicinal product registered for participation in tender, the certificate will be issued only by March 31, 2019. Taking into consideration this legal regulation, from now on the registration certificate will reflect all abovementioned cases and include the line with the exact validity term of the certificate (in the case of first registration), the line «unlimited» (in the case of re-registration of product) and data – March 31, 2019 (in the case of centralized procurements).

In addition, at the applicant’s request, the name and address in the registration certificate may be indicated in English. Moreover, it is allowed to indicate in the document the full, as well as the abbreviate name of the applicant.

Additionally, the registration certificate will reflect the frequency of submission of the regularly updated report on medicinal products’ safety.

After the Order’s entry into force, the following information will be reflected in registration certificate:

• Name of the procedure (registration/re-registration, registration of separate medicinal product or inclusion of changes into registration materials),
• Date and reference number of the Ministry of Health order, which approved the corresponding decision,
• Name of medicinal product/ medicinal immunobiological product,
• Formulation,
• Dosage (with the indication of the number of active ingredient for the dose unit for monoproducts in pre-dosed forms),
• Information on the name and address of the applicant,
• Validity term of registration certificate,
• Date of the expiry of registration certificate,
• Date of printing of original registration certificate.

Certain changes pertained to the registration of active pharmaceutical ingredients (API). In case of simultaneous registration of finished medicinal product and API, which is the part of this product, the application for medicinal product state registration and the application for API state registration should be submitted separately. The expert examination of the materials on API is conducted within one registration dossier for the finished medicinal product. Upon the expertize results, separate recommendations are provided concerning the registration of the finished medicinal product and API, applicants are provided with separate registration certificates with different registration numbers. These numbers are included into State Register of Medicinal Products of Ukraine.