Communicating safety information to patients and healthcare professionals is a public health responsibility and is essential for achieving the objectives of pharmacovigilance in terms of promoting the rational, safe and effective use of medicines, preventing harm from adverse reactions, minimising risks and contributing to the protection of patients and public health. The main emphasis of this article is on direct healthcare professional communication (DHPC). Countries of interest are Macedonia, Serbia, Bosnia & Herzegovina, Montenegro, Albania and Kosovo. Safety communication should deliver relevant, clear, accurate and consistent messages and reach the right audiences at the right time for them to take appropriate action. Readers will get an indepth look at regulation compliance from the emerging markets within country-specific environments.

Serialization is driving operational value and is adding safety securing distribution chain against counterfeit and adulterated products. Developing countries are much more vulnerable to this worldwide problem. Readers will learn about regulatory requirements in the countries of interest: Macedonia, Serbia, Montenegro, Bosnia & Herzegovina, Albania and Kosovo. Readers will get in-depth look concerning safety & labelling and will be updated with the country specific environments, as well as with serialization main benefits and the future perspectives.

A general framework for safety assessment is proposed by the EFSAs Scientific Committee, in which botanicals or botanical preparations for which an adequate body of knowledge exists could benefit from a “presumption of safety” without any need for further testing, based on long history of use without reported adverse effects and without significant larger exposition. Botanicals and botanical preparations for which a presumption of safety is not possible based on available knowledge would be subject to a more extensive safety assessment, requiring additional data to be provided. For these preparations with a potential to contain toxic, addictive, psychotropic or other substances that may be of concern (given in the Compendium), presumption of safety can be applied only if there is convincing evidence that these undesirable substances in the specific plant parts or preparations are either absent in the source material, or significantly reduced if not excluded, or inactivated during processing (EFSA Journal, 2009).