On 17 March 2020 the Cabinet of Ministers adopted new amendments to Cabinet Regulation No. 416 “Procedures Regarding the Distribution and Quality Control of Medicinal Products”. The amendments came into force on 31 March 2020. However, some of them will be coming into force later, by 1 July 2021 latest. The amendments are aimed at developing a more effective and transparent mechanism for medicine sales and quality control, and with a view to resolving complaints about the inaccessibility of medicines.
Distinction between factually and falsely inaccessible medicines
The amendments include several new definitions concerning medicine circulation. A distinction between “factual” and “false” inaccessibility of medicines is introduced. While “factual inaccessibility” is a circumstance in which it is impossible for a medicine producer or wholesaler to deliver medicines due to lack of supply, “false inaccessibility” is a situation in which the wholesaler refuses to deliver medicines despite their being in stock (e.g., the wholesaler has intended these stocks for export).
Effective mechanism for supervising medicine circulation
The amendments envisage a new supervisory mechanism for wholesale of medicines, setting an obligation for wholesalers to provide information on changes in medicine supplies to the State Medicines Agency by the end of each working day. Previously the data had to be provided only once in a half year.
Moreover, medicine wholesalers are now obliged to keep an electronic record of all medicine sale and purchase transactions by using invoices, consignments, import or export declarations or other documents which may help the authorities to immediately access the necessary data.
In addition, a new, more transparent medicine ordering mechanism for pharmacies has been developed. Further, if a required medicine is not in stock, pharmacies will be able to order it from any of the importers or wholesalers which have it in stock according to the information available on the State Medicines Agency website.
If an order is rejected despite the medicine being available in accordance with State Medicines Agency data, the pharmacy has to inform the Health Inspectorate, which may carry out a further investigation and in future even apply penalties. Pharmacies must now store data on rejected orders for one year and officials from the State Medicines Agency have the right to access this at any time.
Amendments to medicine distribution regulation
Several minor clarifications and updates have been made in relation to the duties and rights of wholesalers. Further, not only the Health Inspectorate, but also State Medicines Agency officials will be authorised to carry out inspections of wholesalers’ premises, equipment and installations.
Starting from 1 July 2020 a restriction on the export of certain medicines may be applied if the marketing authorization holder or wholesaler has announced a suspension of delivery or there has been factual inaccessibility of medicines during the past three months. Any information on restrictions will be published on the State Medicines Agency website.
From 1 July 2021 each medicine wholesaler will be required to appoint someone responsible for compliance with good sales practice. Only pharmacists with at least one year’s experience in wholesale will be allowed in this position.
The amendments now allow registered medicines to be distributed six months after termination of registration, unless termination is due to quality, safety and efficiency issues. The same rule applies in relation to Authorisation for Distribution of Parallel Imported Medicinal Products.
To implement an easier procedure for distribution of unregistered medicines, changes have been made in the procedure for issuing permits for medicinal products for compassionate use. Permits will no longer be issued to healthcare institutions. Instead they will be issued to wholesalers, which will be allowed to supply institutions with medicine.
Changes in the parallel import procedure
Parallel importers are no longer obliged to suspend distribution of medicinal products if variations concern significant parts of the registration documentation of medicinal products. However, the importer will have to inform the State Medicines Agency if any changes are made regarding information on the supplier, imported medicine or re-packaging procedure of a medicine. Some amendments have also been made in the Submission Regarding Parallel Imported Medicinal Products and the Authorisation for Distribution of Parallel Imported Medicinal Products templates.