The Ministry of Health Has Cut the Gordian Knot: the Order for the Authentication of Registration Materials Has Been Established

The Ministry of Health has registered decree № 721 dating 03.11.2015 ''Concerning the Approval of the Order for the Authenticity Examination of the Registration Materials Related to Medicinal Products Submitted for State Registration with the Purpose of their Purchase by a Specialized Organization"(hereinafter – the Order).

The Order provides for a simplified assessment procedure of the registration materials for the medicinal products that are purchased on budgetary funds via specialized international organizations. In particular, the State Expert Centre (SEC) examines only the authentication of the registration materials for the mentioned product category. Such assessment establishes the existence of authenticity of the Ukrainian translation of the medication instruction (information), approved in accordance with the regulatory requirements of the state of the applicant / producer or a state, whose regulatory authorities are guided by high standards of quality, which comply with those recommended by the WHO, and / or according to the results of clinical trials.

Therefore, as opposed to the general procedure, the assessment does not provide for the conduct of a preliminary or specialized examination of registered materials for the validation of quality, safety and effectiveness of the medicinal product.

It is to be noted that in order to conduct the assessment for the authentication of materials, a batch of documents is submitted, which differs from the one required for the general assessment. As such, the following documents are attached alongside the declaration on state registration;

• The materials from the register dossier, which were submitted to the state authority at the place where the product has been registered for the registration of the medicinal product or for the reclassification of this medicinal product by the WHO.
• The evaluation report of the medicinal product, compiled by the authorities of the state where the product is registered or issued by the WHO if the product has been reclassified.
• Control methods of the medicinal product's quality (final product) (information concerning the quality assurance of medicinal products (final product)).
• Instructions on the administration of the medication or information on the administration of the medication, approved in accordance with the regulatory requirements of the applicant’s/producer's state or a state whose regulatory authorities are guided by high standards of quality, which are compatible with those recommended by the WHO, and / or according to the results of clinical trials.
• A sample of the medicinal product's original packaging.
• A certified translation of the package labeling text in Ukrainian.
• A Ukrainian translation of the medication's instruction for use or the medicinal product’s usage information approved in accordance with the regulatory requirements of the applicant’s/producer's state or a state whose regulatory authorities are guided by high standards of quality, which are compatible with those recommended by the WHO, and / or according to the results of clinical trials the authenticity of which is verified.

It is to be noted that unlike the general procedure, the applicant submits all of the documents to the Ministry of Health, which in turn forwards on its' own within one working day the documents required for the assessment to the State Expert Centre.

It should also be noted that the deadline for the conduct of the assessment is five working days. However, the expertise of the materials of the medication, which is submitted for the State registration with a full dossier can continue for up to 210 working days.

In accordance with the results of the authentication expertise, the SEC compiles a conclusion, which is forwarded to the Ministry of Health within one working day.

It is to be reminded that under current legislation the Ministry of Health has 7 working days (as opposed to 1 month for the general procedure) to make a decision concerning the state registration of a medicinal product, which is procured by international organizations.

It is emphasized that the Order comes into force on the date of its' official publication.