The Medicines and Healthcare products Regulatory Agency (MHRA) has established guidelines "Medicines: Register to manufacture, import or distribute Active Substances" in the UK. These guidelines ensure that all active substances comply with regulatory standards, safeguarding public health and maintaining product quality throughout the pharmaceutical supply chain.
Active Pharmaceutical Ingredient (API): The substance in a pharmaceutical drug that produces its intended therapeutic effect.
Why Registration is Required
Entities engaged in the manufacture, import, or distribution of active substances within the UK are legally required to register with the MHRA. This requirement ensures that active substances meet regulatory safety and quality standards. Registration also facilitates regular inspections and compliance monitoring.
The Registration Process
To apply for registration, companies must follow these steps:
Access the MHRA Portal: Submit applications through the MHRA PCL Portal.
Provide Company Details: Include information on the business’s legal status, operational address, and authorized representatives.
Submit Product Information: Provide details about the active substances being manufactured, imported, or distributed.
Comply with GMP or GDP Standards: Ensure facilities are in compliance with relevant standards.
Pay Applicable Fees: Fees will be calculated based on the application type and the required inspections.
Registration Timelines
New applications: 60 working days (excluding time for additional information or data).
New applications requiring inspection: 90 days.
Variations not needing inspection: 30 working days.
Variations needing inspection: 90 working days.
Registered entities must strictly adhere to Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) standards. If an inspection is required, an MHRA inspector will contact the applicant to arrange a site inspection. Upon successful completion of the process and any necessary inspections, the MHRA will issue a registration document.
Registered companies must submit an annual compliance report by 30 April each year via the MHRA portal. This report provides the agency with a summary of activities, ensuring continued compliance with regulatory requirements. If a company ceases its activities related to active substances, it must formally request the termination of its registration. Companies should complete and submit a Termination Form to the MHRA before 31 December to avoid additional fees.
Fees and Payments
The fees vary based on the type of registration and the number of sites involved.
Active Substance Manufacturers:
New application: £5,006 (includes £3,143 application fee and £1,863 desktop assessment fee)
Additional inspection fee (if required): £792
Variation: £257
Assessment of the Annual Compliance Report: £257
Annual Compliance Report requiring a variation: £514
Active Substance Importers and Distributors:
New application: £3,157 (includes £1,803 application fee and £1,354 desktop assessment fee)
Additional inspection fee (if required): £582
Variation: £257
Assessment of the Annual Compliance Report: £257
Annual Compliance Report requiring a variation: £514
Staying updated with the latest guidance and amendments is crucial for maintaining regulatory compliance.
For full details, access the official MHRA guidance here:
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