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Changes to be made in medicines' state registration order in Azerbaijan [UPDATE]

3 May 2018 15:04 (UTC+04:00)
Changes to be made in medicines' state registration order in Azerbaijan [UPDATE]

By Rashid Shirinov

Changes will be made in the order of state registration of medicines in Azerbaijan, and it is planned to amend the law “On medicines” in this regard. The decision was made at the meeting of the Healthcare Committee of the Azerbaijani Parliament on May 3.

During the discussion, Head of the Committee Ahliman Amiraslanov noted that drug advertising is partially allowed in Azerbaijan, but this issue should be reconsidered.

“This advertising is more dangerous than advertising of cigarettes,” Amiraslanov said, adding that drug advertising is prohibited in Europe.

Parviz Azizbayov, head of the Drug Quality Control Inspection under the Analytical Examination Center of the Health Ministry, in turn, proposed to carry out inspections at facilities without warning.

“It will be better if in the future the legislation related to the checks will be amended. Ongoing checks are inefficient, because before checking the facility, people there are warned in advance, and entrepreneurs manage to take the appropriate action,” he said.

Azizbayov emphasized that in this regard, the Health Ministry will prepare proposals for inspections to be carried out without warning.

He reminded that, according to the legislation, unscheduled inspections are carried out only on the basis of complaints, information disseminated in the media, and appeals of the state body.

Health Ministry’s sector head Elkhan Azizov, in turn, noted that the Ministry called on entrepreneurs engaged in pharmaceutical activities to comply with new requirements in this field, which came into force from the beginning of the year.

He noted that the requirements for pharmacies in connection with the sale of drugs are toughened, and those who violate them will be held accountable.

“Depending on the amount of damage inflicted, this may also lead to criminal liability,” Azizov emphasized.

The changes proposed at the Committee’s meeting state that the import of medicines and samples of the substance used in the drug production must be carried out by the relevant executive authorities, enterprises engaged in the production and wholesale of pharmaceutical products, representative offices of foreign manufacturers in Azerbaijan, or, in the absence of a local representative office, an authorized person of a foreign manufacturer.

Also, a change will be made to the Article 8 of the law. The amendment states that all treatment and prophylactic enterprises, the owner of the certificate on registration of medicines and the person authorized by him must carry out work on pharmacovigilance and appoint persons responsible for this sphere.

Moreover, the Article 14 will be amended by a paragraph saying that the trademark of biologically active food additives must not coincide with the trademark of a medicinal product registered by the relevant executive authorities.

Lastly, the Article 16 will be amended by a change, noting that the persons responsible for pharmacovigilance of the treatment and prophylactic enterprises, the owner of the certificate on registration of medicines and the person authorized by him must provide information to the relevant executive authorities on side effects and other problems, as well as information on pharmacovigilance and report documents.

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Rashid Shirinov is AzerNews’ staff journalist, follow him on Twitter: @RashidShirinov

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