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EU Responsible Person

European legislation requires each cosmetic product to have a Responsible Person based inside the EU. The role of the Responsible Person is to ensure full compliance with all European legislation over time.

Why?

For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation. (EU Regulation 1223/2009, Article 4.2).

The obligations of the cosmetics Responsible person are described in the Article 5 of the Regulation, and shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1), (2)and (5), as well as Articles 20, 21, 23 and 24. (EU Regulation 1223/2009/EC, Article 5.1.).

 

The Responsible person, therefore, has to provide or ensure the following:

 

  • Registered address in the EU where the Product Information File is kept readily accessible to the local competent authority in a language easily understood by that competent authority for inspection even 10 years after the last batch of the product has been placed on the market.

  • Product claims substantiation;

  • Correct cosmetic product labeling;

  • Product Information File (PIF) compliance with the Regulation, that the products were produced according to Good manufacturing practice (GMP), that the safety assessment has been conducted etc;

  • CPNP notification of cosmetic products;

  • Communication of any undesirable or serious undesirable effects to the competent authorities;

  • In case of non-conformity of the product with the EU regulation, take any appropriate measures including recall, removal of the products or taking corrective action to bring that product into conformity. At the request of the competent authorities, the Responsible person must cooperate with the former to eliminate the risk posed by cosmetic products which they are the Responsible person for.

Who?

Responsible person (RP) can be any legal or natural person who is based within the EU. Therefore, if the manufacturer is from the EU, they usually act as the RP themselves.

 

Cosmetics manufacturers from outside of the EU, on the other hand, can’t act as the RP themselves. They have an option to either appoint their importer or a distributor as the RP, which is not recommended, since the RP has to keep the Product Information File and all the product secrets with it; or they can appoint a third person or a company (such as Pharmilab) to act as the RP. This person or a company must accept this role in writing.

  

To sum up then:

 

The Responsible person has to be established in the EU.

The Responsible person must be designated by a written mandate, and has to accept this role in writing.

The Responsible person can be the manufacturer (if established in the EU), a distributor, an importer, or a professional (designated) Responsible person.

Pharmilab?

Based on the description of the Responsible person’s duties, you can see that the Responsible person’s job is very important and requires expertise in various areas. 

 

  • By hiring Pharmilab you will have a large technical team with in-depth knowledge of the ever-changing European Union legislation, which will keep you informed of any updates of the legislation so that your company can keep its products in compliance with the legislation of the EU.

  • Pharmilab will be your single point of contact for any regulatory issue in the EU.

  • Pharmilab knows the notification process, executing the notification faster and without errors. Even if your company change distributors, your responsible person will always remain the same, eliminating the need to reprint the labels (the labels should indicate the name and address of the responsible person) and the need to notify your products again.

  • The experienced Pharmilab team will easily answer the questions that any of the 28 EU competent authorities will ask.

  • Pharmilab will keep your product information files with care, keeping all your secrets confidential. Pharmilab is only focused on ensuring the compliance of your products with the applicable legislation and, therefore, does not conflict with your commercial interests.