To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Local Agent/License Holder is mandatory for local compliance. Due to the economic and operational constraints, establishing own subsidiaries in each country may not be feasible for all cosmetic manufacturers. Hence, manufacturers must appoint a Responsible Person for a seamless market entry.

Who Can Act as a Responsible Person (RP)?

  • Local manufacturer
  • Importer/Distributor
  • A specialized third-party company established in the local market

Specialized Regulatory Partner vs. Importer/Distributor as your Responsible Person

Many manufacturers and brand owners choose to appoint their distributors as Responsible Persons/License Holders. However, despite the low cost, this option may not be beneficial in the long run, as various aspects should be considered while selecting a Responsible Person. They include:

I. Areas of Expertise

The company or individual that places a product on the market is responsible for assuring product safety and quality and ensuring compliance with applicable Regulatory requirements. The job description and required skills of a Responsible Person are very specific. Knowledge of the country-specific legislation and the Regulatory expertise to respond to the queries of the Authority are the essential factors for this position.

II. Confidentiality

As per the Regulatory requirements, a copy of the manufacturer's Product Information File (PIF)/confidential documents/dossier must be made available on the premises by the Responsible Person/License Holder. The PIF/dossier contains product formulation, product safety, manufacturing processes, testing data, compliance information, substantiation data of the products’ stated effects and claims, etc. In such a scenario, the manufacturer should have a high degree of trust in their distributor and ensure that the information is handled with the utmost confidentiality.

III. Conflict of Interest/Impartiality

In many circumstances, a distributor’s primary motivation may only be commercial. While this is not necessarily bad, it can lead to conflicts of interest, especially when a distributor works with multiple manufacturers. For example, in terms of expansion, prioritization, or successful lobbying on behalf of other manufacturers, a distributor may have a conflict of interest.

Considering the above factors, it is strongly recommended that the manufacturers appoint a neutral third party as a Responsible Person (RP) to protect their Regulatory interests. Reach out to a proven Regulatory partner for Responsible Person (RP)/Local Agent services in Cosmetic markets of your interest.

 

Related Posts by Category

Global HA Mandates
 
x