Pharmacy licenses in countries of the WHO European Region

All countries in the WHO European Region require a license to open and operate a pharmacy. Most often it is issued by a state authority, but in federal states, the granting of a pharmacy license is regulated at the local level. Applications can be submitted directly or through the e-government system, as in Armenia, Azerbaijan, Georgia and Kazakhstan.

There are two concepts for regulating pharmacy licenses.

• A site-specific pharmacy license is a permit to operate a pharmacy in a specific location or even in a separate premises that undergoes a special inspection before the license is issued. This license can be transferred (sold) automatically when the pharmacy is sold to another owner, provided the owner meets all the requirements. Thus, it is unrestricted and transferable. Typically, this model is used in countries that combine limiting the establishment of out-of-hospital pharmacies (as part of health planning) with restricting ownership to pharmacists only. This is the case, for example, in Belgium, Malta and France. In post-Soviet countries, licenses are issued on a site-specific and non-transferable basis and usually need to be renewed every five years.
• The pharmacy license deals with the legal aspect of running a pharmacy, which may be linked to a specific pharmacist in charge, as for example in Iceland. When the pharmacist in charge is changed, the license is revoked and a new one must be obtained. Such a license is personal and non-transferable. It is by definition time-limited, e.g. it expires when the pharmacist in charge retires or is dismissed.

Most countries in the WHO European Region charge a fixed fee for the granting of a pharmacy license and its renewal may also be subject to a fee. This fee may be the same for all pharmacies or may vary depending on specific criteria. In Malta, for example, it depends on the size of the pharmacy.

The conditions for granting a license vary significantly from country to country. But in any case, the regulator has to make sure that all legal requirements for the pharmacy and its owner are met. For example, in Turkey, where the licensing and territorial distribution of pharmacies is regulated by the government, in order to obtain a license, a pharmacist must submit an electronic application for the position of pharmacy manager and meet all requirements, including higher education, work experience and a certificate from the Chamber of Pharmacists.

Types of pharmacy licenses

In some countries, such as Lithuania, different types of pharmacy licenses are issued depending on whether an out-of-hospital pharmacy is allowed to engage in the individual manufacture of medicines.

In Belarus, there are five types of pharmacy licenses that enable specific activities, such as pharmacy production of medicines and dispensing of drugs and psychotropic drugs.

In Georgia, three categories of pharmacies can obtain a license: pharmacies with internal drug production unit, pharmacies without drug production and pharmacy branches located in hospitals and rural areas. There is no re-licensing procedure for pharmacies due to insufficient number of pharmacy inspectors.

In many CIS countries, the type of pharmacy is determined by space requirements and the availability of production capacity for individualized medicine manufacturing. In order to increase access to medicines in rural areas, national legislation in many countries allows the opening of pharmacies that meet a smaller set of requirements, such as pharmacy outlets and kiosks. Because they are dependent structures, to be licensed as such, the owner must also have a regular pharmacy with a license.

The main difference between a pharmacy outlet and a pharmacy kiosk is usually in the amount of space required, compared to a pharmacy. For example, in Kyrgyzstan there are norms according to which the area of a regular pharmacy should be 75-85 m2 , pharmacy point – only 20 m2 and pharmacy kiosk – only 10 m2.

As a result of these space limitations, the range of pharmacy services is reduced and the focus is on the dispensing of medicines. However, there are exceptions to the general rules. For example, in small villages in Tajikistan, pharmacies are allowed to provide individual manufacturing of medicines.

In many countries, inadequate access to health care in remote areas has become a critical issue. In Kazakhstan, Turkey and Uzbekistan, to improve access to medicines in rural areas, certain pharmacies can organize mobile pharmacy units, such as pharmacy buses. In Uzbekistan, one of the largest pharmaceutical distributors provides mobile pharmacies to improve access to essential medicines in remote areas. Also, medical vehicles have recently been provided in Uzbekistan to act as family clinics in regions where there is such a need. The aim of this innovation is to reduce the burden on emergency medical services, which have been heavily utilized due to lack of access to primary health care services.

License revocation

A license may lapse if a pharmacy ceases to operate or is not established within the allotted period of time after the issuance of the license. Different countries have different practices for the revocation or withdrawal of licenses.

Thus, in Denmark, Germany and Finland, if a license is not used for one year (no pharmacy activity), it is revoked or cancelled. Similar provisions apply in Belgium, but here we are talking about a two-year period.

If a license holder or pharmacy employee violates pharmacy practice laws or licensing requirements, the license may be revoked or canceled temporarily or permanently. Practices that potentially lead to revocation include hiring employees without a college degree in pharmacy, violating dispensing regulations, or dispensing adulterated drugs. In addition:

• In Azerbaijan, Kazakhstan, Tajikistan, Turkmenistan and Ukraine, violation of sanitary-hygienic requirements or fire safety rules is fraught with temporary revocation of the license, and in case of dispensing psychotropic substances without a prescription, it is revoked permanently. In Ukraine, among other things, a pharmacy license is revoked if there is evidence that the license holder is influenced in his/her activities by representatives of the countries conducting military aggression against Ukraine.

• In Belarus, in case of non-compliance with license requirements, the license holder may be given six months to correct deficiencies before the license is revoked. In this country, a pharmacy can also be fined if it fails to stock medicines from the essential list.  In Armenia and Georgia, violation of license requirements also entails serious penalties for the pharmacy owner.

• In the Republic of Moldova, the license is also revoked if the pharmacy staff does not have certificates of completion of advanced training courses or the accreditation criteria are not met.

• Turkey also has strict criteria regarding the presence of a pharmacist with a university degree. If the pharmacist is absent or does not meet the requirements, the pharmacy may be closed for 30 days. Further failure to meet the requirements leads to the revocation of the license.

• In European countries, the requirement to notify the pharmacy regulator when a pharmacy closes temporarily or permanently is common practice, as this may have implications for the planning of the pharmacy network. To maintain continued access to pharmaceutical services, the regulator may also require the pharmacy to continue to operate for a short period of time until a new pharmacy license is issued to another pharmacist.

• In Albania and Germany, a license can also be revoked in case of breach of the code of ethics. This is an additional incentive for pharmacists to adhere to standards of professional and ethical behavior.

Shutterstock/FOTODOM UKRAINE photos were used

1. 1. The legal and regulatory framework for community pharmacies in the WHO European Region. Copenhagen: WHO Regional Office for Europe; 2020. License: CC BY-NC-SA 3.0 IGO.