Regulatory & Compliance
ALG’s Regulatory & Compliance team has significant experience in Healthcare and Life Sciences. We advise Irish and international clients, as well as law firms, on EU and Irish pharmaceutical and healthcare regulatory frameworks and compliance matters across the healthcare, BioPharma, MedTech, animal health, food, and cosmetics sectors. We also assist with regulatory aspects of structuring and due diligence in corporate transactions.
We provide our clients with comprehensive advice on a wide range of issues, including:
- Product classification, authorisation/certification and regulatory requirements throughout the life cycle of each relevant product.
- Promotion, marketing, advertising and hospitality, regulatory requirements, prohibitions and restrictions, codes of practice of industry bodies (medicinal products and medical devices) regulatory guidance and advising on compliance and enforcement risks.
- Reporting transfers of value.
- Licensing, registration, certification and other requirements for manufacturing facilities and activities (MIA, controlled drugs, substances, APIs and chemicals), wholesale distribution facilities (WDA) and supply chain, brokers of medicinal products, laboratory facilities and compliance with GMP and GDP.
- CE marking and advice on the requirements of MDR and IVDR for all actors within the medical device supply chain.
- Market access, pricing and reimbursement, applications to the HSE under the Health (Pricing and Supply of Medical Goods) Act 2013 to gain reimbursement status for medicines, medical devices, special dietary foods etc and on responding to the HSE in respect of price reviews, pricing strategies of the HSE Medicines Management Programme and other pricing initiatives and requests for price reductions. Advising on the IPHA and MFI Framework Agreements for the Supply of Medicines to the HSE.
- Responding to regulatory authorities, conformity assessment bodies, and governmental authorities including HPRA, HIQA, Department of Health and the HSE in respect of adverse findings on inspection, audit and in respect of reviews, inquiries and investigations.
- Irish medical and healthcare law, telemedicine, digital health, and cross border healthcare.
Our experience
Endo International plc on the Irish regulatory aspects of its restructuring prior to sale of substantially all of the group’s assets.
An Irish laboratory advising on a suite of documents to support clinical genetic testing services using genetic sequencing platforms and INAB accreditation.
A global pharmaceutical company advising on its application to the HSE for reimbursement of an anti-retroviral medicine under the Health (Pricing and Supply of Medical Goods) Act 2013 (the 2013 Act).
A multinational nutrition company advising on the HSE Medicines Management Programme proposed process for the identification of preferred high protein oral nutritional supplements and drafting legal submissions based on the 2013 Act, EU and Competition Law.
A global manufacturer of human generic medicines advising on regulatory and compliance issues regarding pricing, promotion, supply chain, High Tech Drugs Scheme and drafting various contractual agreements.
The Irish subsidiary of a US incorporated biotechnology company on the establishment of its Irish operations and regulatory requirements to support its application for a marketing authorisation under the EU centralised procedure and to establish its EU supply chain.
Exponent Private Equity on the Irish regulatory aspects of its acquisition of Chanelle Pharma the largest indigenous pharma company in Ireland and the largest manufacturer of human and veterinary generic pharmaceuticals.
A European listed company advising on the requirements under Irish Law governing extemporaneous compounding of medicinal products.
A global information technology company advising on the lawfulness of a celebrity endorsed sponsored video, posted to the celebrity’s social media account referencing a prescription only medicinal product.
Key contacts
Cliona Christle
Partner, Life Sciences & Healthcare
Róise Nic Ghráinne
Senior Associate, Hospitals & Healthcare
©2025 A&L Goodbody LLP
All rights reserved