In the State Gazette, issue 18 of 1 March 2011 amendments to the Consumer Protection Act (the „CPA”) were promulgated, which have entered into force as of 5 March 2011. The most substantial changes concern the sales of drugs by means of distance contracts (including through electronic trading platforms).
Prior to the entry into force of the discussed changes, the CPA used to prohibit the offering and sale by distance contracts of a broad range of medicinal products, including:
- medicines, food additives and homeopathic products;
- any products presented with a therapeutic effect.
As a result of the discussed changes the scope of this statutory prohibition is significantly narrowed, where it remains to apply only with respect to non-prescription medicinal products (the so called OTC drugs). In practice, there is currently no restriction for non-prescription medicines and also food additives and homeopathic products to be offered and sold by means of distance contracts, including:
- through direct marketing methods (involving the use of printed materials, telephone, electronic mail, etc.);
- by catalogue trading; and
- through online shops and other Internet-based electronic trading systems.
According to the Medicinal Products in Humane Medicine Act, the prescription regime applicable to a medicinal product (by prescription or not by prescription), is determined by the Bulgarian Drug Agency in the market authorisation/registration certificate or in the authorization for parallel import, which it issued for the respective medicinal product on the territory of the Republic of Bulgaria.