Health Authority Regulatory Liaison and Legal Representation

Most of the countries’ regulations require international companies to be represented by a local agent to be responsible for products’ safety in the country. A legal representative is a person and/or entity who is authorized by international manufacturers of pharmaceutical, medical devices, cosmetic or nutraceutical products to represent them in country, locally. This is a requirements as per many countries’ regulations, legislations and laws. The Legal Representative’s role includes Local Representation to the Health Authority (such as US FDA, EMA, MHRA, CDSCO, TGA, HSA, NMPA, NPRA etc.), responsible for products’ safety, respond to HA queries, managing the product compliance from submission of dossier to lifecycle submissions and assist with import and custom clearance.

Often different countries refer to different names/ terminologies for legal representation with more or less similar responsibilities. However, the objective of Health Authorities remains to ensure a local person/agent who is responsible for the safety of the products marketed in the country. Some of the terminologies include, Responsible Person, Local Agent, Local Representative, Authorized Agent, In-Country Caretaker, Local Sponsor etc.

A local representative in most countries must have,

• Qualified person with educational qualification or experience in pharmaceutical or related lifesciences industry (usually a pharmacist with license)
• Locally registered business to act as MAH or legal representative
• Necessary Manufacturing / Wholesale / Retail license for pharma, medical devices, food, cosmetic products
• A warehouse with cold storage as per local regulatory legal requirements and specifications
• GDP compliance warehouse is required in some countries where audits are conducted by the HA
• Import Export License for facilitation of imports
• Accounts or Access to Online Submission portals (such as PRISM in Singapore, SUGAM in Pakistan etc.)
• Valid country identity numbers or cards (CorpPass, Aadhar etc.)

Often international manufacturers face challenges in finding right local representatives. Some of the challenges include.

• Finding a qualified person with required technical expertise and experience with regulations
• Understanding of global standards, approach and ability to bridge with local requirements for technical requirements, communication, project management etc.
• Communication (both spoken and written) proficiency in both English and Local language
• Lack of transparency
• Experience and size of team for managing multiple activities
• Lack of planning and proactively solving problems that could arise locally, often reactive way of working leading to issues and non-compliance
• Lack of defined processes, issues with data security and intellectual property safety

• Pharma Wizard provides comprehensive legal representation and Health Authority (HA) liaison support across multiple global markets. We have established local offices and in-country teams in key regions, and we further extend our reach through long-term collaborations with qualified regional regulatory experts who are authorized to act as local representatives.

• In each market, we leverage our local presence, regional licenses, warehouses, industry networks, and in-depth HA experience. Combined with our proven regulatory project management capabilities, we ensure a seamless, compliant, and efficient experience for our clients.