General information on the market

  • Regulatory:

All drugs must be registered in advance in Albania, then be traded in accordance with the law. Applications, the files of drugs, and all the processes of evaluation for registration are under the authority of the National Agency of Drugs and Medical Devices (NADMD or AKBPM )

NADMD represents an institution specialized in the analysis, controls, and registration of drugs. She operates her activity under the Ministry of Health.

Registration of a drug is approved and signed in its final stage by the Minister of Health (the highest authority)

NADMD is responsible for the registration of drugs, licensing of pharmaceutical activity, a pharmaceutical inspection of each level, importation, storage, distribution, determining prices, advertising, etc.

  • Determining prices:

Ministry of Health makes strict control over prices of drugs and the structure of their determining.

Actually, profit margins for importers/distributors and pharmacies, as defined by the Law on Drugs, are respectively 11% and 25%. All medicines are equipped with a stamp that shows the sales price (patient price) and it informs about the import authorization and permit authorization, issued by NADMD, for that number series of drugs.

This price is calculated based on the profit margins mentioned above and the approved CIF price for that drug. All foreign companies that have products registered in Albania must declare CIF prices of these drugs every year.

  • Reimbursement list:

Currently, this list includes 506 drugs of different therapeutic areas (or 280 molecules). For these drugs, the Compulsory Insurance Fund Healthcare covers a fraction of the total cost, which varies from 25% to 100% (full refund). Full refunds are for drugs such as anti-cancer, especially those for ambulatory use and those used for the treatment of cancers with high incidence in the population

The quote of reimbursement is higher for drugs that are used for chronic treatment and also the drugs used mainly by children and pensioners.

For these drugs, the profit margins are estimated at 8 % and 24%.