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UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration & reclassification such as "Register to manufacture, import or distribute active substances", "Register as a broker" and "Reclassify your product".

Guidance: Medicines: Register to Manufacture, Import, or Distribute Active Substances

This guidance details how to Register as a manufacturer, importer, or distributor of active substances. MHRA has issued a flowchart on the registration requirements that helps to decide what kind of registration the manufacturer needs.

It takes 60 working days for a new application to be processed, excluding time spent providing additional information or data, and 90 days for an inspection to be conducted.

A variation to registration without an inspection takes 30 working days and one that requires an inspection takes 90 working days.

In order to prevent a possible impact on the safety and quality of other substances, new active substances must be added immediately to the registration; otherwise, the substances may be notified in your annual compliance report.

Guidance: Medicines: Register as a Broker

A UK-based company that independently negotiates the selling or buying of medicines on the behalf of another company must be registered as a Broker. A broker does not:

  • buy or sell the products

  • own the products

  • physically handle the products

A broker must comply with good distribution practice (GDP) and must pass regular GDP inspections to be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Guidance: Medicines: Reclassify your product

Medications are classified according to the amount of health professional input required for diagnosis and treatment. Currently, there are three categories by which medicine can be classified:

  1. Prescription-Only Medicine (POM)

  2. Pharmacy (P)

  3. General Sales List (GSL)

Click this LINK to know more about how to apply to move medicine to a different classification.

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