Meeting with representatives of the European Business Association

Опубліковано 17.08.2020 о 09:38

 

During the meeting held at the State Service of Ukraine Medicines and Drugs Control with the representatives of the EBA Health Care Committee the implementation of amendments to the Procedure approved by the Order of the Ministry of Health of Ukraine as of 09.06.2020 № 1346 were disscused. Meanwhile the following issues were raised during the meeting: conduct of remote assessment of compliance of manufacture conditions with the GMP requirements, providing conclusion on confirmation of compliance of medicinal products manufacture conditions with copies of reristration certificates issued by the competent authorities of the EU coutries, or other EU member-coutries, Great Britain or coutries which have munutal recognition with EU or Ukraine.

Participants also discussed the involment of scientists and proffesionals into the conduct of expertise, inspection, performance of certain works of enterprises, institutions, organizsations, implementation of precise requirements to the procedure of chargeable services, maintenance of confidential information while involving GMP inspectors of the SE «Ukrainian Pharmaceutical Quality Institute» and SE «Central Laboratory for Drugs Quality Analysis and Medicinal Products» into the expertise and inspection procedure.

The State Service of Ukraine on Medicines and Drugs Control paid attention to guarantees of carrying out obligations in accordance with the part VII of the Procedure by the State Service of Ukraine on Medicines and Drugs Control and GMP inspectors of the SE «Ukrainian Pharmaceutical Quality Institute» and SE «Central Laboratory for Drugs Quality Analysis and Medicinal Products» on maintenance of confidential information about Applicant and/or manufacture, and/or representative including information received during inspection; absence of conflict of interest while inspecting and conducting works on confirmation of compliance of manufacture conditions with the GMP requirements; non-disclosure of confidential information and commercial secrecy of an Applicant and/or manufacture.

Upon request of the European Business Association the SE «Ukrainian Pharmaceutical Quality Institute» with involvment of the State Service of Ukraine on Medicines and Drugs Control will conduct a conference (webinar) to provide cosultations on core points of the Procedure of compliance of medicinal products manufacture conditions with the GMP requirements approved by the Order of the Ministry of Health of Ukraine as of 09.06.2020 № 1346.

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