Cyprus manufacturing sector is comparatively smaller than other countries within the EU, however, among the main industrial products manufactured in Cyprus, is pharmaceuticals. The industry of medicine and pharmaceuticals in Cyprus has grown during the last decade, although during the crisis of 2013 the industry faced a significant crisis itself. Today, medicine and pharmaceuticals industry, is one of the most promising and most strong-becoming industries in Cyprus, advancing research and new technology, and attracting foreign investors, at the same time.
Our law firm assists domestic and multinational companies with pharmaceuticals, biotechnology, medical devices, cosmetics and food supplement issues. We provide our clients advices on gaining and maintaining market access, on submission of strategies and documentations to the competent authorities and trade associations, and assist them to overcome the challenges posed by this complex industry.
We provide advices to healthcare services groups, pharmaceutical, biotech, medical device companies, insurers and banks in corporate finance, mergers and acquisitions, tax regulations, competition law, IP and anti-trust projects, licensing and distribution and clinical trial advices. We assist our clients to establish their business in Cyprus or expand their Cyprus – based business within the EU and vice versa, whether through M&A, joint ventures or distribution agreements.
In order to wholesale medicinal products in Cyprus, a Wholesale Licence for medicinal products is required to be obtained by the Registrar Drugs Council of the Pharmaceutical Services of the Ministry of Health. Licenced wholesalers of medicinal products must comply with the Medicinal Products for Human Use (Control of Quality, Supply and Prices) Laws of 2001 and the Medicinal Products for Human Use (Procedure and Content of Examination for a Wholesale Licence) Regulations. Our expert team is able to advise you in regard to the relevant regulatory requirements, guide you through the drafting and submission of your application to the Registrar and ensure that your business will be in compliance with the requirements of domestic and EU law, including the EU Drug Safety, Pharmacovigilance, and Quality System regulations.
Regarding the abovementioned practices, our expert team may provide the following services:
- Advice on regulations and licensing, ensuring our clients’ compliance with the relevant regulations on authorisation, licensing, marketing, pricing, labelling and promotion of their products;
- Advice on compliance and ethics, preparing codes of conduct and securing our clients’ compliance with the EU regulations, domestic laws and directives of Cyprus Pharmaceutical Services Department;
- Advice on competition and anti-trust laws and representation of clients to anti-trust proceedings and investigations;
- Advice and implementation of M&A transactions, including all legal, regulatory, corporate and commercial aspects;
- Advice on data protection issues such as collection and processing of patients’ health or personal data and disclosure of such information and representation of clients to clinical trials;
- Representation of clients before the competent authorities and administrative bodies;
- Represantation of clients to investigations by the Cyprus Pharmaceutical Services Department and to court actions brought by or against our clients by the Cyprus Pharmaceutical Services Department;
- Negotiating, drafting and reviewing commercial agreements, including distribution and licensing agreements of our clients with third parties
- Public procurement appeals in regard to tender offers, processes and awards.