Regulatory Affairs Department (RA)
Regulatory Affairs Department (RA) of Pharmaceutical Company is responsible to obtain approvals for new pharmaceutical products and ensuring that maintenance will be in place as long as company wants to have the product in the market.
Regulatory affairs specialists act as an intermediary between companies and state regulatory authorities, ensuring that products are manufactured and distributed in accordance with appropriate legislation. The profession offers opportunities for international travel and employment.
The laws and regulations that are being worked on today by the specialists of this sector are:
- Law on drugs and pharmaceutical service 105/2014 “On drugs and pharmaceutical service”
- Law No. 89/2014 “On Medical Devices”
- Law No. 7975 “On Narcotic Drugs and Psychotropic Substances”
- Decision no. 508, dated 10.6.2015 for the approval of the technical rule “On Essential Requirements, Conformity Assessment and CE Marking of Active Implantable Medical Devices
- Decision no. 731, dated 2.9.2015 for the approval of the technical rule “On Essential Requirements, Conformity Assessment, Classification and CE Marking of Medical Devices
- Decision No. 189, dated 9.3.2016 for the approval of the technical rule “On Essential Requirements, CE Marking and Conformity Assessment of In Vitro Diagnostic Medical Devices
- Order no. 360 dated 22.08.2016 “On Procedures and Rules for Registration of Medical Devices, Changes and Cancellation of Their Registration, Necessary Documentation and Related Costs
- Medical Equipment Registration Form
- Order no. 734 dated 18.10.2019 for some changes in order no. 360 dated 22.08.2016 “On Procedures and Rules for Registration of Medical Devices, Changes and Cancellation of Their Registration, Necessary Documentation and Related Costs”
To be updated on the latest news in the regulatory field, use the official website of the Cometary Agency for Medicines and Medical Devices:
