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On 28.07.2020 in the State Gazette vol. 67, the latest amendments to the Medicinal Products in Human Medicine Act were promulgated (SG vol. 31 of 13.04.2007, last amended and supplemented SG vol. 67 of 28.07.2020) (the ‘Act’), which aims to create the preconditions for the implementation of Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules on safety features appearing on the packaging of medicinal products for human use (“Delegated Regulation (EU) 2016/161”), including optimization of the control over pharmacies. Summary information about the changes can be found below.
I. REDUCTION OF ADMINISTRATIVE BURDEN
Pursuant to Decision No. 704 of the Council of Ministers of 2018 on the adoption of measures for transformation of the model of administrative services, the Act provides for measures to limit the administrative burden on citizens and legal entities in the registration regimes related to trade in medicinal products.
With respect to the above, there is no need for the presentation of a certificate for lack of criminal record by Bulgarian citizens when applying for a permit for (i) manufacture of medicinal products; (ii) for imports of medicinal products; (iii) wholesale of medicinal products; (iv) retail trade in medicinal products in pharmacies; and (v) drugstores. The same approach is applied in case of a subsequent change in any of the persons performing the specified activities.
In addition, the Bulgarian Drug Agency (BDA) will establish ex officio the circumstances regarding the existence of an usage permit or a certificate for commissioning of the sites for production, control and storage, issued under the Spatial Planning Act, or an another valid document within the meaning of the Spatial Planning Act.
Last but not least, when applying for a permit for retail trade in medicinal products in a pharmacy, the obligation to provide a hygienic opinion by the relevant regional health inspectorate will not apply, and the same will be required ex officio by the BDA.
II. WHOLESALE vs RETAIL TRADE in medicinal products
With the adoption of the amendments to the Act, the activities “wholesale of medicinal products” and “retail trade in medicinal products in a pharmacy” is prohibited to be performed by one and the same person / legal entity. Until 28.07.2020, the Act did not provide for such a restriction and the persons / legal entities which received valid permits to exercise the two activities could exercise them in compliance with the relevant legal requirements.
Within six months, namely until 31.01.2021, according to § 70, para. 1 of the Act, the persons who hold both a wholesale trade permit and a permit for retail trade in medicinal products in a pharmacy, issued before the entry into force of the Act, should bring their activity in compliance with the requirements of the Act.
In case the respective person has not brought his activity in compliance with the new prohibition within this term, the executive director of BDA shall revoke the permit, which was issued with a later date. When the second type of activity is a retail trade in medicinal products, the Executive Director of the BDA will revoke the permits issued to the person for all pharmacies.
The new ban on combining the two activities of wholesale and retail trade in pharmacies of medicinal products also applies to the applications submitted before 31.07.2020.
III. Application of DELEGATED REGULATION (EU) 2016/161
In order to create preconditions for the implementation of Delegated Regulation (EU) 2016/161, the Act provides for the following new registers and obligations to the persons exercising activity under the Medicinal Products in Human Medicine Act.
- National number of medicinal products
The BDA, within 3 months from the entry into force of the Act or until October 31, 2020, should generate a unique national number for identification of each medicinal product and enter it in the register of authorized and registered medicinal products on the territory of the Republic of Bulgaria and medicinal products authorized for use under a centralized procedure pursuant to Regulation (EC) (726/2004 of the European Parliament and of the Council.
- Preventing the entry of counterfeit medicines
With the entry into force of the changes to the Act, it is envisaged that all participants in the legal supply chain of medicinal products will check whether the medicinal products have not been counterfeited, by verifying their authenticity through the safety indicators under the law.
Sanctions: For non-compliance with the obligations regarding safety indicators, the Act provides for the imposition of a fine or a property sanction, which may reach up to BGN 20 000 for holders of a permit for manufacturing or import, use or parallel import, and in case of repeated violation up to BGN 50 000. There are smaller sanctions for retailers.
IV. SALE OF MEDICINAL PRODUCTS
- Prohibition of return
With the adoption of the changes to the Act, a practice has been documented that pharmacies cannot replace or return already purchased medicinal products. According to art. 234, para. 5 of the Act, as of 31.07.2020, the return of purchased medicinal products is explicitly prohibited.
- Mandatory pricing
According to the latest amendments to the Act, a medicinal product may be sold on the territory of the country only after the entry into force of the decision of the National Council on Prices and Reimbursement of Medicinal Products established by the Minister of Health (the “Council”) for determination of a price or registration of a price, except for the cases provided by law.
In that respect, a medicinal product may not be sold at a price higher than the approved price (for medicinal products included in the Positive Drug List*), the marginal price (medicinal products subject to medical prescription in accordance with the lowest reference prices from Member States) or the registered maximum price (for non-prescription medicinal products).
The Act also provides for restrictions on the formation of the final price of medicinal products that will be paid by medical institutions, as well as the products included in the value of medical care provided.
In addition, medicinal products included in the Positive Medicinal List, which are paid for under the Social Security Act, are not subject to a surcharge for a retailer when they are sold in a pharmacy.
The aim of introducing restrictions on the pricing of medicinal products is to achieve greater control over the trade in medicinal products and transparency in payments between traders and users throughout the supply chain.
*The Positive Drug List is prepared and maintained by the Council and includes medicinal products dispensed on prescription and paid for with funds from the NHIF budget, from the state budget outside the scope of compulsory health insurance, from the budget of medical institutions and from the budget of state-owned medical institutions and / or municipal participation.
V. NATIONAL PHARMACY MAP
The adoption of the Law changes provided for the creation of the so-called National Pharmacy Map, which aims to determine the needs of the population for access to medicinal products on a territorial basis.
The National Pharmacy Map will determine the districts, municipalities and cities with a shortage of open pharmacies by performing an analysis of the population’s access to pharmacies that carry out activities on:
- granting of medicinal products for home treatment, paid in full or in part by the National Health Insurance Fund;
- preparation of medicinal products;
- granting of medicinal products, containing narcotic substances in the sense of the Control over the Narcotic Substances and the Precursors Act;
- dispensing of medicinal products under a doctor’s prescription, which are not paid with public funds;
- dispensing of medicinal products without a doctor’s prescription, etc.
The National Pharmacy Map will be elaborated on the basis of regional pharmacy maps.
The law stipulates that the National Pharmacy Map shall contain data on:
- the regional pharmacy maps;
- the specific minimum needs of the population for access to medicinal products, dispensed in pharmacies, and to the types of activities, by districts, municipalities and cities;
- distribution of the opened pharmacies by number of the population by districts, municipalities and cities;
- graphic indication of the opened pharmacies on the map of the country according to the type of the activities they perform;
- analysis of the access of the population to medicinal products, dispensed in pharmacies by types of activities by districts, municipalities and cities;
- determination of the districts, the municipalities and cities, in which during the analysis a shortage of open pharmacies by types of activities has been established.
The National Pharmacy Map should be adopted by a decision of the Council of Ministers on a proposal of the Minister of Health within one year from the entry into force of the Act, namely by 31.07.2021.
*This text does not constitute a legal advice and should not be taken into account in resolving legal disputes, but only to inform readers.
The team of Georgiev, Todorov & Co. Law Offices remains available for assistance and additional information related to the implementation of the changes to the Medicinal Products in Human Medicine Act.