Regulatory Affairs & Compliance

MedicalGroup’s Regulatory Affairs team is responsible for all issues related to product registration and licensing and safety and compliance. It’s a tall order, with no less than five sets of laws and directives to keep track of in Kosovo alone, for instance – not to mention the GxP rules and regulations we adhere to independently, on our own accord.

Our in-house pharmacists handle all procedures related to new product registration, from preparing dossiers for a given product to securing the licenses required for that product’s import, sale and distribution. Leaving these procedures to our experienced staff saves our manufacturing partners considerable time and money. 

Safety, efficacy and quality are core values at Medical Group, and we actively promote these values across our network, from the doctors and pharmacists who prescribe/dispense the products we distribute straight through to the patients/customers they serve.

Unfortunately, counterfeiting and smuggling remain serious problems in the Balkans. MG’s position on these issues is clear: As a matter of policy, MG staff are required to report all instances of suspected counterfeit and/or unlicensed trade to our compliance officers, who then (if confirmed) inform the appropriate authorities. We also often team up with our manufacturing partners, pharmacists in our network, and/or local authorities to educate the general public as to the risks posed by the presence of counterfeit medicines in the communities we serve.