Deregulation in pharmacy. The government is simplifying the rules for confirming qualifications

June 17, 2025. The Council of Ministers has approved a bill to amend the Pharmaceutical Law, prepared by the Minister of Health. This is part of the government's deregulation efforts to simplify and standardize regulations in the health sector, without introducing new barriers for professionals.

The project focuses on updating the requirements for key employees in the pharmaceutical industry:

• Qualified Person - that is, a specialist responsible for the quality and safety of medicinal products in pharmaceutical companies;
• Competent Person - an expert who oversees the safety of individually prepared drugs in the hospital setting.

The requirements for these positions have been aligned with the current classification of higher education majors, in accordance with the current Law on Higher Education and Science. The purpose of the changes is to increase the consistency of the regulations and bring them in line with modern educational and professional realities.

Detailed rules for confirming qualifications - including a list of necessary documents - will be set forth in a Health Ministry regulation. The regulations do not tighten the existing requirements, but only clarify their description. For employers, this means greater clarity and certainty in hiring qualified people.

The draft also provides for transitional provisions - those who already serve as a Qualified Person or Competent Person and meet the existing conditions will be able to continue their work without the need to obtain additional authorizations.

The changes are part of a broader deregulatory strategy aimed at simplifying regulations without lowering patient safety and drug quality standards.

Source: KPRM