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Estonia · Law · SE

299

Act on Amendments to the Medicines Act, the Health Insurance Act and the Health Services Organization Act

avaldatud riigiteatajasEstonia· Riigikogu· ET

Introduced

27 September 2023

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Status

AVALDATUD_RIIGITEATAJAS

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Source updated

23 November 2023

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Summary

The bill updates the Medicines Act and brings it into line with EU law, as well as reducing the unnecessary administrative burden on the parties to the pharmaceutical market. The changes provided for in the bill improve the availability of medicines and develop pharmacy services. According to the bill, in the future, consumers will be allowed to return drug waste to pharmacies in a simplified manner. Currently, when returning medicines, a transfer-acceptance document must be drawn up, which shows the name of the transferor, the name and quantity of the medicinal preparation and the act must be signed by the parties. Pharmacies are also given the opportunity to provide advice on traveling with medicines and to issue Schengen certificates necessary for traveling with medicines. Currently, this is done by the Medicines Board. In addition, it is possible for the pharmacy to dispense medicines prepared or dispensed based on a doctor's prescription to other pharmacies, thereby enabling patients to receive such medicines to them from a suitable pharmacy. By supplementing the current procedure, the activity license for the wholesale sale or production of pharmaceuticals automatically includes the right to import and export goods that require a special permit, and it is no longer necessary to stipulate special conditions for the permits. The draft also specifies who is the importer and exporter of medicines, replacing the request for a medicine export permit and the request for the import of medicines without a sales permit from a member state of the European Economic Area with a notification procedure, thus reducing administrative burden. The possibility for the holder of a drug production license to carry out wholesale activities in addition to production without holding a wholesale license will be abolished. The requirements for drug advertising will also be updated. In the future, in addition to the holder of the marketing authorization, it will be possible to hold responsible for the violation of the requirements of drug advertising also the advertiser, publicist and executor who commits the violation. The bill regulates in more detail the possibility of guaranteeing Estonian patients access to new drugs being developed in situations where there are no other options for the treatment of a chronic or life-threatening disease, and the availability of innovative drugs and methods has remained the only possible solution for the patient. Also, in order to ensure the continuous availability of medicines, the Medicines Agency is given the right in exceptional cases (for example, in case of delivery difficulties) to temporarily limit the quantities of medicines dispensed from the pharmacy or to allow issuing only for certain diagnoses.

Machine translation from Estonian. The official text remains authoritative.

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31 official files

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