Responsible person (RP) for UK & Authorised Representative for EU Market Access
To legally place your products on the UK and EU markets, non-UK manufacturers must appoint a responsible person and authorised person (RP). This is a mandatory legal requirement under regulations for cosmetics, medical devices, and other product categories.
Medivdpharma (MIP) acts as your designated Responsible Person, providing the essential legal representation and regulatory expertise you need to ensure compliance, maintain market access, and guarantee product safety.
What Does a Responsible Person (RP) & Authorised Representative do?
As your officially designated RP, MIP provides a comprehensive suite of services to ensure full regulatory compliance:
- Legal Representation: We act as your authorized legal entity in the UK and EU, serving as the primary point of contact for regulatory authorities like the UK MHRA and EU Competent Authorities.
- Product Compliance Assurance: We verify that your products and their formulations meet all applicable UK and EU safety, labelling, and regulatory standards.
- Documentation Management: We compile, maintain, and ensure the constant readiness of your critical technical documentation, including the Product Information File (PIF) for cosmetics or technical files for devices.
- Regulatory Notification Management: We handle all mandatory product submissions on your behalf, including notifications via the UK MHRA portal and the EU Cosmetic Products Notification Portal (CPNP).
- Post-Market Surveillance & Vigilance: We manage cosmetovigilance or device vigilance, monitoring and reporting any adverse events or consumer complaints to the relevant authorities as required by law.
- Authority Liaison: We manage all communication with regulatory bodies, responding to inquiries and facilitating any audits or requests for information efficiently.
- Labelling Compliance: We review and approve your product labelling to ensure it meets all requirements, including the correct placement of our RP address.
Why Partner with MIPas as Your Responsible Person/ Authorised Representative?
Formulating and implementing business goals. We begin with an in-depth analysis of your business and market to identify opportunities and challenges. From there, we work with you to define clear, actionable.
Guaranteed Market Access
Fulfill the legal requirement to sell your products in the lucrative UK and EU markets without establishing a physical presence.
Operational Efficiency
Free up your internal resources to focus on core business activities like production and marketing, while we manage all regulatory obligations.
Expert Compliance Management
Navigate the complex and evolving regulatory landscape with confidence, ensuring ongoing compliance and reducing risk.
Cost-Effective
Solution
Avoid the significant financial expense of hiring and training an in-house regulatory compliance team by leveraging our expert professional services.
Our Seamless Process:
- We begin by certifying your products and labels for full UK/EU compliance.
- Once verified, we formally appoint ourselves as your Responsible Person/ Authorised Representative.
- We provide you with our official UK and EU address for use on your product labels and for regulatory correspondence.
