Ensuring the quality, efficacy, safety and pricing of medicinal products for human use which are available to the public is a key concern in strengthening and protecting public health. In addition, ensuring the quality and safety of cosmetic products in the local market is also essential for consumer protection. In order to achieve the above, the Pharmaceutical Services aim to provide high quality evaluation services at pre- and post-approval level, as well as inspection and control / supervision services. The activities of the Pharmaceutical Services, regarding the licencing and marketing of medicinal products for human use are legally regulated in accordance with the Medicines for Human Use (Control of Quality, Supply and Pricing) Law of 2001 (70 (I) / 2001), which is in full harmonisation with Community Directive 2001/83/EC, as amended. In addition, the circulation and control of cosmetic products is governed by the provisions of the Cosmetics Law N57(I)/2017 and the relevant Regulations.
The licensing of medicinal products for human use requires a thorough scientific evaluation of their quality, safety and efficacy by suitably qualified pharmacists/assessors of the regulatory affairs, pharmacovigilance and clinical trials sectors. Medicinal products are assessed either through national procedures, or through cooperation with EU Member States for the centralised, decentralised and mutual recognition procedures.
As of 1 January 2020, Cyprus has taken on the role of Reference Member State in decentralised and mutual recognition procedures, conducting a full scientific evaluation of applications and contributing to the licensing and marketing of medicinal products for human use in the other Member States. It is expected that Cyprus adopting the role as a Reference Member State will bring significant benefits to the local pharmaceutical companies, which will benefit from low fees, will no longer have to rely on other Member States for the relevant licenses and will be able to market their products in the other Member States, thus increasing their turnover.
The responsibility for monitoring the use and safety of medicinal products for human use after their licencing rests with the pharmacovigilance and clinical trials sectors which, in accordance with Legislation 70(I)/2001 and based on the relevant European guidelines (GVPs), manages the pharmacovigilance system, aiming to minimize any risks that arise and to protect patients.
The inspection of manufacturers, wholesalers and private pharmacies is an essential function of the control/supervision of pharmaceutical activities which aim to ensure a high quality supply chain of medicinal products in the Cyprus market.
Accordingly, the inspection of manufacturers and market surveillance for cosmetic products in accordance with the relevant legal requirements and Regulations, are aimed at consumer safety and protection.
The Good Manufacturing Practice and Distribution (GMPD) Inspectorate carries out inspections of manufacturers and wholesalers/distributors to determine the level of compliance with the relevant legal requirements of Law 70(I)/2001 and the relevant guidelines, as well as cosmetic manufacturing facilities, preventing unacceptable and/or illegal practices.
The Pharmacy Inspections/Pharmacist Registration Sector, in accordance with the Pharmacy and Poisons Law (Cap.254), conducts inspections of private pharmacies as well as inspections of narcotics and psychotropic substances, and is responsible for the registration of pharmacists.
The Medicinal Product Pricing Sector handles all issues and policies governing the pricing of medicinal products for human use, and is responsible for the annual update of the price list of medicinal products.