Pharmaceuticals

We provide specialized legal services in the field of pharmaceuticals regulation, focusing on both Cyprus and the European Union (EU) markets. With an in-depth understanding of the regulatory frameworks governing the pharmaceutical industry, we offer strategic advice and tailored solutions to assist clients through the pharmaceutical regulations.

Our key Practice Areas include:

• Regulatory Compliance - We assist pharmaceutical companies in ensuring compliance with the extensive regulatory requirements at both the national and EU levels. Our team advises on matters such as marketing authorizations, product labeling, packaging requirements, pharmacovigilance, clinical trials, and post-marketing obligations. We stay abreast of the latest regulatory developments, helping clients adapt their practices to evolving requirements.
• Market Access and Licensing - We guide clients through the process of obtaining market access and licensing for pharmaceutical products in Cyprus and the EU. This includes advising on regulatory procedures, preparing and submitting applications, and assisting with interactions with regulatory authorities such as the Cyprus Pharmaceutical Services Body of the Ministry of Health and the European Medicines Agency (EMA).
• Intellectual Property Protection - Our team provides counsel on intellectual property matters specific to the pharmaceutical industry. We assist clients in securing and enforcing patent rights, conducting freedom-to-operate searches, negotiating licensing agreements, and handling patent disputes and litigation.
• Data Privacy and Data Protection - With the increasing importance of data privacy and protection, we offer guidance on compliance with relevant regulations, such as the General Data Protection Regulation (GDPR) and local data protection laws. We assist clients in implementing privacy policies, data transfer agreements, and ensuring compliance with data security requirements.
• Pricing and Reimbursement - We advise clients on pricing and reimbursement strategies for pharmaceutical products, both at the national level in Cyprus and within the EU. Our team assists in navigating pricing regulations, reimbursement systems, and negotiations with health authorities and payers.
• Advertising and Promotion - We provide guidance on pharmaceutical advertising and promotional activities to ensure compliance with regulations governing the marketing and promotion of pharmaceutical products. This includes reviewing advertising materials, advising on labeling and promotional content, and assisting with compliance with advertising codes and guidelines.

At AGPLAW we aim to provide comprehensive and practical legal support to pharmaceutical companies. Our goal is to assist clients in navigating the complex Pharma regulatory landscape, achieving compliance, protecting their intellectual property, and optimizing market access for their pharmaceutical products.