Amendments to the procedure for examination of registration materials are possible

The Ministry of Health of Ukraine has published a draft amending theProcedure For Conducting Expert Evaluation of Registration Materials for Medicinal Products Submitted for State Registration (Re-Registration), as well as Expert Evaluation of Materials for Changes to the Registration Materials during the Validity of the Registration Certificate (hereinafter - the Procedure / the draft).

The Procedure is aimed to establish that the conclusions and recommendations should be drawn up by the State Expert Centre of the Ministry of Health of Ukraine (hereinafter – the Centre) in the form of list of medicinal products recommended / not corresponding to recommendations in the registration, re-registration, amending registration materials and entering into the State Registry of Medicinal Products of Ukraine. It is proposed to add expert conclusions about the efficacy, safety and quality of medicinal products and copies of the leaflets of medicinal products, pharmacopoeia articles or methods of quality control, containing package labelling. Such materials should be sent to the Ministry for decision adopting.

In addition, the draft provides for that the cost of expert evaluation and the registration fee will not be returned to the applicant in the case of a withdrawal application from consideration. Herewith, the applicant will be able to use them to pay for other expert works in the Centre. It is also proposed not to conduct expert evaluation of changes to the registration dossier in case of change of address of the manufacturer and / or applicant.

An important change is the elimination of the need to conduct additional studies to validate the quality of medicinal products and replicability of quality control methods of medicinal products by the registration of certain categories of medicinal products. Medicinal products are included to such category:

• if a medicinal product is prequalified by WHO;
• if a medicinal product is registered in the country, which regulatory authorities apply high quality standards that meet the standards recommended by the WHO, in particular the EU Member States, Switzerland, UK, USA, Canada, Japan, Australia, Iceland and Liechtenstein.

Pleas recall that the possibility of pre-registration control using indicators of quality of such medicinal products by the procedure "Lot Release is provided for in the current version".

Furthermore, it is proposed not to conduct additional studies to validate the quality of medicinal products andreplicability of quality control methods of medicinal products in the following cases:

• Original (innovative) medicinal products for the treatment of socially dangerous diseases (tuberculosis, HIV / AIDS, viral hepatitis, as well as the medicinal product with original molecule for the treatment of rare diseases), medical immunobiological products used in the implementation of specific immunization of infectious diseases included in the calendar of preventive vaccinations in Ukraine and registered in the country, to which regulatory authorities apply high quality standards that meet the standards recommended by the WHO;
• Medicinal products for the treatment of tuberculosis or HIV / AIDS, medical immunobiological products used in the implementation of specific immunization of infectious diseases, which are included in the vaccination schedule based on age, and have undergone retraining and are included in the WHO list of prequalified medicinal products;
• Medical immunobiological products used in the implementation of specific immunization of infectious diseases, which are included in the vaccination schedule based on epidemic indications and have been prequalified by WHO and included in the list of WHO prequalified medicines.