Law on Health Care Protection

Pharmacy institution

Organizing and performing pharmacy activities in the Republic of Serbia is performed following the Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019), the law governing health insurance, the law governing drugs and the law governing medical devices, as well as the Guide to Good Pharmacy Practice, issued by the Pharmaceutical Chamber of Serbia, with the consent of the Minister.

The Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019), among other things, regulates the concept of pharmacy activity, activities that include pharmacy activity, as well as forms of organization that shall perform pharmacy activity.

Pharmacy activity on the territory of the Republic of Serbia is performed in:

  • pharmacy institution
  • pharmacies of the health centre, i.e. pharmacies as an organizational part of another health institution at the primary level of health care, following the law
  • pharmacies as an organizational part of a health institution at the secondary or tertiary level of health care, i.e. a health institution that performs activities at several levels of health care, i.e. in a hospital pharmacy
  • private practice pharmacies.

Pharmacy, in terms of the Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019), means a pharmacy institution, a private practice pharmacy, a pharmacy of a health centre and a pharmacy as an organizational part of another health institution at the primary level of health care, under the law.

Pharmacy activity is a healthy activity that provides pharmaceutical health care to citizens and is carried out through the health care system and performed at the primary, secondary and tertiary level of health care and in private practice.

In addition to the sale of medicines and medical devices at retail, the pharmacy may also sell other products for the promotion and preservation of health and items of general use following the law. The list of products that, in addition to medicines and medical devices, can be sold in pharmacies is prescribed by the Minister.

The pharmacy activity is performed by a master of pharmacy, i.e. a master of pharmacy with the appropriate specialization and a pharmaceutical technician with the proper health school profession.

Establishment and organization of a pharmacy institution

The pharmacy institution performs pharmacy activity at the primary level of health care, following the law.

A publicly owned pharmacy institution is established by a local self-government unit, following the Network Plan.

The Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019) regulate conditions for the establishment of the privately-owned pharmacy institution.

The founder of a pharmacy institution may be the Republic, an autonomous province, local self-government, a legal entity or natural person, under the conditions prescribed by the Law on Health Care Protection (“Official Gazette of the RS”, No. 25/2019).

The pharmacy institution may have branches, which can be organized on the territory of the Republic of Serbia.

To establish and perform pharmacy activity, a branch of a pharmacy institution must meet the same conditions in terms of space, staff, equipment, medicines and medical devices, prescribed by this law and regulations adopted for the implementation of the Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019), as well as the seat of the pharmacy institution.

The seat of the pharmacy institution, as well as its branches, may have organizational units outside the headquarters, i.e. branch office, organized as:

  • pharmacy unit
  • pharmacy station
  • central warehouse
  • galenic pharmacy laboratory
  • control laboratory.

The seat of the pharmacy institution, as well as its branches, may have a maximum of four organizational units outside the seat, i.e. branch office. Organizational units may be organized within the same administrative district in which the headquarters or branch of the pharmacy institution is located.

As an organizational unit, the pharmacy station is organized in a rural area, i.e. in a settlement at least five kilometres away from the nearest pharmacy.

The organizational unit of a pharmacy institution may bear the name provided by the Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019) for that type of organizational unit if it meets the conditions prescribed by the Law on Health Care Protection (“Official Gazette of RS” No. 25/2019) and regulations adopted for the implementation of the Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019).

A pharmacy institution may perform pharmacy activity if the health inspector of the Ministry of Health determines by a decision that the prescribed conditions for performing pharmacy activity are met.

Requirements regarding staff, equipment, premises and medicines are specified in detail by the Rulebook on detailed conditions for performing health care activities in health care institutions and other forms of health care service (“Official Gazette of RS”, No. 43/2006, 112/2009, 50/2010, 79/2011, 10/2012 – other regulations, 119/2012 – other regulations, 22/2013 and 16/2018). Based on the decision to fulfil the prescribed conditions for performing pharmacy activity, the pharmacy institution, its headquarters, branches, and their organizational units are entered in the Register of Health Institutions, which is kept in the Serbian Business Registers Agency, following the law.ess Registers Agency

The pharmacy institution may perform only the pharmacy activity, which is determined by the decision of the Ministry of Health on the fulfilment of the prescribed conditions for achieving the pharmacy activity.

Galenic laboratory within the pharmacy institution

The production of galenic drugs can be performed only by the health institution-pharmacy, i.e. the organizational part of the stationary health institution (hospital pharmacy), which has a galenic laboratory for which the competent ministry has issued a license for the production of galenic drugs, and which relates to particular pharmaceuticals form of galenic drug and a specific galenic drug.

The galenic laboratory of the pharmacy, i.e. the hospital pharmacy, performs the production of galenic drugs following the law governing the field of medicines and medical devices, the provisions of the Rulebook on conditions for the production of galenic drugs (“Official Gazette of RS”, No. 10/2012), and the license for the production of galenic medications issued by the competent ministry.

Production of galenic drugs in the galenic laboratory of a health institution – pharmacy in small batches, up to 300 ready individual packages per batch, which are intended for issuance, sale, i.e. use and application for patients of that pharmacy, i.e. pharmacy which is part of another health institution, that is, a pharmacy that performs activities at the primary level of health care, i.e. a pharmacy established as a private practice, is not considered to be the production of drugs in the sense of the law governing the field of medicines and medical devices.

The production of galenic drugs in the galenic laboratory of a hospital pharmacy that performs health care activities at the secondary or tertiary level of health care, in the amount required to provide health care to patients of that health care institution, is not considered drug production in terms of the law governing the field of medicines and medical devices.

The applicant for a license for the production of galenic drugs in the galenic laboratory can only be a health institution that meets the requirements following:

  1. Law on Medicines and Medical Devices (“Official Gazette of RS”, No. 30/2010, 107/2012, 113/2017 – other law and 105/2017 – other law)
  2. Rulebook on conditions for the production of galenic drugs (“Official Gazette of RS”, No. 10/2012) and
  3. Rulebook on galenic drugs used in human medicine (“Official Gazette of RS”, No. 85/2011, 101/2014 and 41/2016).

Read more:
Types, Requirements for Setting up and Termination of Work of Private Practice »
Labour inspection – jurisdiction and inspection »

Leave a Reply

Your email address will not be published.