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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".

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.

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).

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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