On September 13, 2019, on the EAEU legal portal docs.eaeunion.org published Recommendation of the EEC Board No. 28 “On the Guidelines for Determining the Scope of Laboratory Tests in the Examination of Medicines”. The document adopted on September 10, 2019.
According to the information provided, member states of the Eurasian Economic Union, starting from the date of publication of this Recommendation, should use this Guide when determining the scope of laboratory tests during registration, confirmation of registration and amendments to the registration dossier of a drug.
The document states that the provision of samples, specific reagents and other materials is not required if it is not possible to conduct tests in an expert organization due to the inaccessibility of drug samples (including when they are classified as orphan, narcotic, psychotropic, radiopharmaceutical), the inability to comply with the conditions for the transportation of these samples to the customs territory of member states of the EAEC and (or) storage, without special equipment and consumables in an expert organization. In these cases, laboratory tests are conducted in the quality control laboratory of the manufacturer of the drug in the presence of representatives of the expert organization or in the contract laboratory used by the manufacturer in the presence of representatives of the expert organization.