Importers of medicines cannot assess now how the State Service of Ukraine on Medicines and Drug Control took into account remarks to the draft new rules to receive GMP certificates, Executive Director of the EBA Healthcare Committee Natalia Serhienko has said.

"At the moment, based on the table of comments published by the State Medicines Service to the received remarks to the draft rules, there is still no clear understanding which of the comments will be accurately taken into account by the State Medicines Service in the updated version of the draft rules," she told Interfax-Ukraine.

Serhienko said that in the context of comments on the rules for confirming the original PIC/S GMP certificates already received by the manufacturers in Ukraine, "there is still no certainty that one of the most important issues will be solved - the possibility of extending the GMP conclusion."

"The issue is fundamental and directly affects the availability of medicines for patients. In the EU, the issued GMP certificate is valid until the next inspection and the issuance of a new certificate. For drug manufacturers, the absence of the possibility of extending the certificates would mean that it is necessary to stop the production and import of a medicine to Ukraine until a new original GMP certificate and then a new conclusion in Ukraine are received," she said, pointing out that "this would also mean that the procedure of registration/re-registration of a certain drug will be delayed for an indefinite period."

"These are significant and absolutely obvious risks of a lack of medicines for patients," the expert said.

Serhienko said that the grounds for suspending the GMP compliance in Ukraine must be reviewed.

"According to the practices of the EU member states, in the case of a reasonable suspension of the turnover of a certain series of medicinal products, this does not lead to the suspension of the GMP certificate, which is issued for the entire production site. A suspension of the certificate would mean stopping the production of all medicines at the respective production site. Suspension is a lack of supplies of appropriate drugs to a particular market," she said.

The expert said that in the new draft rules the grounds for suspension of the conclusion in Ukraine should be carefully worked out and set out in a way "that this tool should be used only for individual series of medicines, if there are appropriate justifications for this".