General information 

Regulatory:
All drugs must be registered in advance in Albania, then to be trade in accordance with law. Aplications, the files of drugs and all the process of evaluation for registration are under of the authority of National Agency of Drugs and Medical Devices (NADMD or AKBPM )
NADMD represent an institution specialized in 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 registration of drugs, licensing of pharmaceutical activity, pharmaceutical inspection of each level, importation, storage, distribution, determining prices, advertising, etc.

Determining prices:

Ministry of Health is making 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 which shows the sales price (patient price) and it inform about the import authorization and permit authorization, issued by NADMD, for that number series of drug.
This price is calculated based on the profit margins mentioned above and declared CIF price for that drug. All foreign companies that have products registered in Albania must declare CIF prices of these drugs per year.

Reimbursement list:
Currently this list includes 506 drugs of different therapeutic areas (or 280 active principles). 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 is for drugs such as anticancer, 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 which 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%.

The turnover of the Albanian pharmaceutical market is estimated to be around 85 million Euro, of which 25 million are provided by the Fund of Compulsory Health and 60 million belong to the wholesale market and retail of medicines.
Meanwhile, purchases carried out by regional hospitals and tertiary health care services through annual tenders organized by the Ministry of Health, reaching a value of approximately 20 million Euro (including medicines, medical materials and devices)