EEU: new rules for manufacturers of medical products

When the EEU common pharmaceutical market is launched, manufacturers of medicinal products will be required to follow the new rules
EEU: new rules for manufacturers of medical products
05 July 14:14 2016 Print This Article

The rules regulating the emerging common pharmaceutical market of the Eurasian Economic Union (EEU) don’t provide for an unconditional recognition of GMP (Good Manufacturing Practice) Certificates issued by non-EEU countries. In fact, to assure safety and quality of medical products produced in third countries pharmaceutical manufactures will have to follow the new EEU regulations, reads the press release of the Eurasian Economic Commission (EEC) citing Arman Shakkaliev, the Director of the EEC Technical Regulation Department as saying during one of the working meeting of the EEC.

The EEU drug safety control legislation had been developed with European standards in mind, Mr Shakkaliev said. For example, the draft Rules for registration and analysis of medical products for human use were developed based on EU Directive 2001/83/ЕЕС. Whereas, the EEU draft Good Manufacturing Practice complies with the GMP EU revised in 2015.

However, according to the new standards “the Drug Master File will have to include a GMP Certificate that complies with the EEU Good Manufacturing Practice. Whereby, in the first three years after introduction of this standard, producers of medicinal products registered in the MS of the Union may present a document issued in compliance with the national standards instead of the EEU GMP Certificate, and third countries’ manufactures — a report of compliance with national GMP requirements of the EEU member states. Should during the examination of the Drug Master File it is discovered that the documents mentioned above are missing, production facilities manufacturing and carrying out quality control of the medicine will be subjected to an unscheduled inspection,” reads the EEC statement.

The EEU is ready to launch a common pharmaceutical market as soon as 19 draft regulations on regulation of drugs circulation are approved. In particular it concerns the Concept of Harmonisation of the Pharmacopoeias of the Member States of the Eurasian Economic Union; five documents focusing on the good laboratory, clinical, manufacturing, pharmacovigilance and distribution practices; Requirements to a patient information leaflet; Rules of analysis of medicinal products; Medicinal products labeling requirements; documents that regulate inspection procedures, etc.

All the documents have been approved by the Board of the EEC. However, the final approval of the ‘package’ at the level of the EEC Council is still pending.

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