New version of the rules for storage and control of quality of medicinal products in medio-prophylactic establishments (further Rules) was approved by order of Ministry of Health Care of Ukraine № 610 dated April 3, 2018. The order came into force on July 10, 2018.
Henceforth, it is permitted to purchase medicines not only from the providers, that have licences on production and/or wholesale or retail trade, but also on import of medicinal products.
Medio-prophylactic establishments (further MPE) should keep copies of licences of providers, documents, confirming the fact of purchase; covering documents, confirming quality of medicinal products, enclosed with the agreement on supplies, during 5 years.
A series of changes according to input control of quality of medicinal products in MPE was made.
It could be done not only by chief/ head nurces but also nurces. There should be a 10-days term for conveying information about authorized person to territorial organ of State service of Ukraine on medicins and drugs control (further Statemedservice) according to the location of MPE.
Input control of quality of medicinal agents is implemented not later than the next day from the date of receiving medicinal agents on the place of accepting production. Medicinal products should be kept in quarantine till legalizing of written conclusion of input control.
In case of suspicion according to quality of medications, an authorized person checks medicinal products by opening packages relatively to size, form, colour, homogeneity, quantity of units in a package, presence of dirtiness. If results of input control are negative, authorized person conveys a copy of a drawn up report on discovered defects together with a conclusion and other documents on a medicinal product during 10 days to territorial authority of Statemedservice.
Besides, some requirements to conditions of storage medicinal products and corresponding rooms in MPE were added. Thus, Rules provide the following:
• rooms for keeping should be equipped with thermometer and hydrometer; notes about temperature and relative humidity should be regularly checked by an authorized person;
• medicines, which are purchased for budget funds, should be kept on a separate shelf/ case with corresponding marking;
• it is necessary to make complete visual control of package condition, exterior view of medicinal products and control of observance the conditions of storage of them not fewer once a month;
• joint storage of medicinal products with chemicals, biologic material, etc. is not permitted;
• a requirement on storage of ready medicinal products in a package with a label on it, and also other rules are absent.
If necessary, it is possible to break the package of producer by medical staff of MPE with an obligatory notation about title, batch, dosage, expiration date, producer of the medicinal agent, conditions for charging and own signature of a person, who made a package, on a newly made package.
According to new rules, medicinal products in quarantine could be returned to use after receiving a positive conclusion about their quality from Statemedservice and after repeated visual control by an authorized person. Implementation of repeated control should be formalized in written form. The Rules also do not contain any norms, which assume implementation of scheduled inspections not oftener than once a calendar year, and unplanned ones – only on the instructions of President of Ukraine, Verkhovna Rada (Government), Cabinet of Ministers of Ukraine, Ministry of Health Care, on appeal or demand of other state control and law-enforcement and local authorities.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
