Essential rules for pharmacies, drugstores and optical retailers in Bulgaria

Permitting regime: pharmacies

Under Bulgarian Law, pharmacies are healthcare institutions in which the following activities are carried out: storage, preparation, packaging, control, consultation, and dispensing of prescription and non-prescription medicinal products authorised for marketing in Bulgaria. Pharmacies may also offer medical devices, dietary foods for special medical purposes and dietary foods for infants for special medical purposes and follow-on formulae, as well as food supplements, cosmetic products, health and hygiene products and certain biocide products in line with Regulation (EU) No. 528/2012.

Pharmacies may operate only upon receiving a retail permit from the Bulgarian Drug Agency (BDA). The applicant can be a natural or legal person registered as a trader under Bulgarian law or an EU Member State. A single trader may open no more than four pharmacies in Bulgaria.

Changes in the retail permit holder can be carried out by terminating the existing retail permit and submitting a new application by the incoming entity. Retail permits cannot be transferred between entities.

The specific regulatory requirements for the premises intended to be used as pharmacies are specified in Ordinance No. 28 of 9 December 2008 on the structure, order and organisation of the work of pharmacies and the nomenclature of medicinal products.

Another key requirement is for a Master pharmacist to be appointed as the pharmacy manager. The manager must be present onsite and may manage only one pharmacy.

Online sales are only permitted for non-prescription ("OTC") medicinal products and may be conducted only by pharmacies with permits. Pharmacies permitted to sell online are listed in a publicly accessible list, maintained by the BDA.

In cases involving the retail and storage of medicinal products containing narcotic substances, the Act on the Control of Narcotic Substances and Precursors ("ACNSP") applies, requiring an additional licence. Registration under the ACNSP must follow the issuance of the retail permit.

Registration regime: drugstores

OTC products, as well as certain health-related goods (i.e. food supplements) and medical devices, can be sold in specialised retail shops known as "drogery" (drugstores). Drugstores are not pharmacies and they cannot retail prescription medicinal products.

Drugstores may sell OTCs online.

Both individuals and legal entities registered under Bulgarian or EU law are eligible to open and operate a drugstore, provided the manager is a qualified medical professional with at least one year of relevant experience and a clean professional and criminal record.

The process of opening a drugstore requires registration with the Regional Health Inspectorate ("RHI"), submission of specific documents and payment of a state fee. The RHI maintains both local and national registers of licensed drugstores, and any changes in address or management must be notified and registered according to the established procedure.

Notification regime: optical retailers and cosmetics counters

Under the Bulgarian Health Act ("Закон за здравето"), optical retailers and facilities used for the storage and trade of cosmetic products as retail shops ("cosmetics counters") are defined as public-use facilities ("обекти с обществено предназначение").

The Health Act and Ordinance No. 19 of 27 August 2008 on the organisation and activities of opticians and the health requirements for them ("Наредба № 19 от 27.08.2008 г. за устройството и дейността на оптиките и здравните изисквания към тях") provide the main legal framework for the operation of optical retailers in Bulgaria.

Persons intending to operate an optical retail facility are obliged to notify the relevant RHI at the facility's location no later than the day on which the activity commences. The notification must include the facility's address, the types of activities carried out in it, as well as the name and permanent address of the person or entity carrying out the commercial activity. Operators must notify the competent RHI of any registered changes (e.g. in address, activity, ownership) within seven days, along with relevant documents.

Where any ophthalmic and optical devices are sold, the Medical Devices Act also applies, and products must comply with conformity assessment procedures.

The procedure for opening cosmetics counters is the same, following the requirements for notification before the relevant RHI under Ordinance No. 9 of 21 March 2005 on the conditions and procedure for creating and maintaining a public register of public-use facilities controlled by the RHI.

Pharmacies, drugstores, cosmetics counters and optical retailers should also be registered as commercial establishments under the applicable local municipal ordinances.

author: Alexandra Minioti