Health Authority Regulatory Liaison and Legal Representation

Your Local Representative for In-Country Requirements and Marketing Authorization Holder with proven Experience in Ensuring Safety, Compliance and Successfully Managing HA Relations

Services We Offer

Authorized Local Representation Across Regions

Artixio’s presence in 120+ countries worldwide through its direct offices and local regulatory associates positions it to act as your trusted partner for your lifesciences products roll out and act as Marketing Authorization Holder in markets of your strategic interest. Artixio’s local teams have 15-35 years of experience in managing Health Authority relations, navigating regulations and legislations for complex new drugs, biologics, biosimilars, medical devices, generics, diagnostics, cosmetics, nutraceuticals, food supplements and animal health, veterinary products.

Once you partner with Artixio as your appointed authorized agent or local legal representative in a country, Artixio will represent you to the Health Authority and be responsible for your products’ safety and compliance. Our support encompasses regular HA meetings, interactions to assist consultations, pre-submission strategy, dossier submission and post approval maintenance of license as per regional laws and legal requirements.

Process:

Appoint Artixio* as Your Authorized Agent

Artixio will represent you before the country’s Health Authority

Assist with HA Meetings and Consultation (strategy consultation, pre-submission meetings)

Submit dossier and product registration application

Seek Approval License

Obtain Import License and Coordinate with Distributors for Import of product and Custom Clearance

Post Approval Maintenance of License

Legal Representative / Authorized In-Country Representative

Responsible for your product’s safety in the country

Respond to HA queries

Act as Marketing Authorization Holder (MAH)

Renewals, Variations, Artwork / Labeling Submissions, Response to Safety Queries, Line Extension, Custom Clearance, GMP/GDP Audits etc

Responsible for overall product compliance

We Ensure Your Product and Brand’s Safety Through Compliance:

Regional Regulatory Experts with Excellent HA Insights to Navigate Complex Regulations
Proven Experience in Successful Registrations
HA / Trade Associations / Industry Network to Keep Track of Regulatory Changes
Fully Compliant with Local Licenses to Represent International Manufacturers Locally
GDP Compliant Warehouses where required
Highly Qualified Experts for Regulatory, Pharmacovigilance, Medical Affairs
End to End support across Registration, GMP/GDP, Import, Custom Clearance, Distributors Management, Clinical Trials, Testing and other logistics support
Regulatory Intelligence Platform: Tech-Enabled Regional Insights based on Regulations, Laws and Experience
Global Best Practices to Regional Success

FAQS

What is the Role of a Legal Representative for Regulatory Affairs?

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.

What are some others terms used for Legal Representative?

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.

What are the requirements for a Local Representative?

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 India etc.)
Valid country identity numbers or cards (CorpPass, Aadhar etc.)

What challenges do international companies face working with local representatives?

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

How do you Support Legal Representation / HA Liaison in different countries?

Artixio has local offices and team members in different countries. In addition, we extend our support to other countries working with our long-term regional regulatory experts who are qualified to act as local representatives. We are currently representing over 5000 products in global markets across Asia, Latam, Europe and North America where products include new drugs, generics, biologics, biosimilars, cosmetics, nutraceuticals, food supplements and animal health. In all these countries, we leverage Artixio and our experts local presence, regional licenses, warehouse, industry network, HA experience and internal regulatory project delivery excellence to support our clients seamlessly.