Prepared intends to resume the work of the regional laboratories for quality analysis of medicines

The state service on medicinal products and control over circulation of narcotic substances (Gosleksluzhba) intends to resume work at the laboratories analysis of the quality of drugs that are part of territorial bodies of the Ministry.

“For the equipping of laboratories for the quality analysis of medicines were expended large sums of public funds. It is impossible to ensure that the equipment has not been used as intended and gradually turned into scrap metal”, – reported on the Agency’s website, citing its head Nataliya Gudz.

She noted that currently civil service completed the audit of territorial departments and according to its results will decide on the revision of the structure of the territorial bodies.

N. Gudz also said that the Republic intends to work on improving procedures for destruction and disposal of medicines, and also on bringing to the European requirements in the area of market surveillance of medical devices .

“Be prepared repeatedly pointed out: if the subject holds the European certificate of conformity, the actual duplication of certification procedures in Ukraine, which requires time and resources, it is inexpedient” – considers the head of Department.

In addition, N. Gudz announced plans of the Administration to improve the issues of trafficking in narcotic drugs, psychotropic substances, precursors and combating their illicit trafficking, and develop policy in respect of pharmaceutical institutions, and also contribute to resolving a number of issues related to import of medicines.

“The regulator has offered the pharmaceutical community following the decision. Importer can be a manufacturer that operates in our own warehouse zones, distributor, and other authorized entities in a customs warehouse. Accordingly, to the customs warehouse we will propose the same requirements as a distributor – compliance with equipment, storage requirements, staff”, she said.

N. Gudz also noted problems with the formation of the layout of the packaging of the drug in the Ukrainian language.

“In my own experience I know how carefully examine Ukrainian marking the Indian manufacturer. And some European manufacturers (or their representatives) generally do not bother about this, investing in the packaging of multiple instructions or even feeding on the control a few packages. And the first Ukrainian packaging sees and verifies our employee with the territorial service,” she said.

The head of the Administration stressed that in nine months, the Department has developed 26 projects of normative-legal acts, however, were adopted only three.

As reported, in late November the government of Ukraine at a meeting on Wednesday appointed N. Gudz head of Saump. Her candidacy was selected on the basis of the National Agency of Ukraine on civil service (Nacholibre) of the competition. Prior to the appointment of N. Gudz with the end of 2011 led the Moscow territorial Directorate of the Administration.

Leave a comment

Confirm that you are not a bot - select a man with raised hand: