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:
Prescription-Only Medicine (POM)
Pharmacy (P)
General Sales List (GSL)
Click this LINK to know more about how to apply to move medicine to a different classification.