Responsible Person & Local Agent

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Responsible Person (RP) & U.S. Agent 

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP provides comprehensive global regulatory affairs services, leveraging our expertise to navigate market-specific regulations and ensure your products are safe, effective, and compliant with both local and international standards, enabling seamless export and distribution.

 

Appointing a regulatory specialist as RP or U.S. Agent: Essential Insights for Your Business

Some countries require companies producing or distributing food, dietary supplements, cosmetics, medical devices, drugs, and pesticide products outside their borders to designate a Responsible Person (RP) within the country. The RP communicates with relevant authorities and ensures compliance with product regulations, making it essential to understand their role, responsibilities, and the benefits of appointing one.

We provide professional RP and U.S. Agent services to help clients meet the regulatory requirements of their target markets, leveraging our global network to facilitate product exports worldwide.

KGMP Product GAP Analysis Service

Roles and Responsibilities of the U.S. Agent in United States.

The U.S. Food and Drug Administration (FDA) or U.S. Environmental Protection Agency (EPA) requires companies located outside of the United States to designate a U.S. Agent when registering with FDA or EPA. The U.S. Agent acts on behalf of foreign manufacturers and suppliers during the registration process and communicates with the FDA or EPA if necessary.

Click to View

The responsibilities of the U.S. agent are limited and include:

• Assisting FDA/EPA in communications with the foreign establishment

• Assisting FDA/EPA in scheduling inspections of the foreign establishment and

• If FDA/EPA is unable to contact the foreign establishment directly or expeditiously, they may provide information or documents to the U.S. Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Note: Please note that the U.S. Agent is not responsible of adverse events reporting, notifications, registration, or any compliance-related responsibility concerning the product or establishment under FDA or EPA regulations.

Roles and Responsibilities of the Responsible Person (RP) in EU or UK.

The Responsible Person (RP) is a designated individual or entity within the European Union (EU) responsible for ensuring that products comply with EU regulations before being placed on the market. This includes ensuring compliance with product safety, Good Manufacturing Practice (GMP) guidelines, product technical file, product notification or registration, labeling, claims, and the communication of undesirable or serious undesirable effects. ※ To enter the GB market, a UK Responsible Person (UKRP) with a registered place of business in the UK must be designated, and compliance with UK regulations must be ensured.

Click to View

The responsibilities of the RP are limited and include:

•  Assisting EU or UK competent authorities in communications

•  Submitting product notifications or registrations

•  Maintaining the product technical file for 10 years after the product is registered under EU or UK regulation

•  Assisting with compliance to product regulations and monitoring regulatory updates

•  Assisting competent authorities in scheduling inspections of the foreign establishment

Note: Please note that the RP is not responsible for adverse events reporting, notifications, registrations, or any compliance-related responsibility concerning products or establishments for which we do not provide services.

Remember that different regulations apply in each country.

Contact us today to discover how our RP and U.S. Agent services can benefit your business.

KGMP simplifies compliance with complex global regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final products.

U.S. FDA Compliance	Health CANADA Compliance	MFDS Compliance
EU & UK Compliance	ASEAN Compliance	NMPA Compliance

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

Global expertise	Quality audit	Scientific expertise	Training	1:1 Consulting

Our professional, dynamic, and pragmatic team is ready to assist you with information and training.

Copyright ⓒ 2012 by KGMP Corp. ALL RIGHTS RESERVED.

© KGMP CORP. and KGMP CORP. RA Consulting, since 2012. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to KGMP CORP. and KGMP CORP. RA Consulting with appropriate and specific direction to the original content.