When submitting notifications of intent to import an unlicensed medicine to the MHRA importers must complete and submit a notification form.

Only licensed importers may submit a notification form. This means only the holders of:

• a Manufacturer’s “Specials” Licence (MSL) can notify the MHRA if importing a medicine from a country other than an approved country for import or if you are in Northern Ireland from outside the EEA (you will need to supply supporting documents)
• a Wholesale Dealer’s Licence (WDA (H)) can notify the MHRA if importing a medicine from a country on an approved country for import list

In the form Importers must provide:

• Importer name and contact details;
• Name and address of the importing site named on their licence which will be performing the importation;
• Number of the WDA or MSL;
• Date of the notification to the MHRA;
• Form reference number - This is a specific reference number for each form. This is different from the individual notifications unique references. This “Form reference number” may be used in the e-mail subject when submitting notifications and related communications to the MHRA;
• Completed Notification particulars - Each line in the excel spreadsheet form is an individual independent notification. Multiple notifications by the same importer for the same site may be submitted in the same notification form by simply completing additional lines. Each notification will need its own unique reference. Different product codes may be included in the same form.

Once completed, the excel form and supportive documentation must be submitted as e-mail attachments to imports@mhra.gov.uk.

Notification particulars:

Notification unique reference (no more than 16 characters)

This is your reference number that is unique for the individual notification. It should be made of numbers and/or letters and should not include spaces or special characters.

Product Code (no more than 16 characters)

This is a code generated by each individual importer to define the unlicensed medicine and its supply chain. It should be made of numbers and/or letters and should not include spaces or special characters.

A product code defines:

• Non-proprietary Name (INN, Generic Name, BAN)
• Proprietary Name (Brand name)
• Strength and pharmaceutical form
• Pack size
• Manufacturer of the finished medicinal product, its name and address
• Country where the finished medicinal product is imported from
• Country where the finished medicinal product is licensed

If any of these parameters is different, a different code will be required. However, if these parameters are the same then the same code should be used.

Quantity (No. of Packs)

This is the total number of packs to be imported per individual notification. Usually, this number is capped at 25 unless otherwise justified. Additional information is available in MHRA Guidance note 14.

Country imported from

Country where the packs of the unlicensed medicine are imported from before coming to the UK.

Country of Licence/authorisation

Country where the medicine is licensed or authorised. If the packs to be imported into the UK are unlicensed anywhere, it should be stated.

Supplier (if not manufacturer)

Name and address of the supplier of the packs to be imported into the UK in the country of origin. More than one supplier may be included.

Country of Manufacture

Country of the manufacturing site of the finished product.

Name and address of the manufacturer of medicinal product

The full name and address of the manufacturer of the finished product. Only one may be reported per notification. Different manufacturers would require different product codes.

Non-proprietary Name (INN, Generic Name, BAN)

International Non-proprietary Name (INN), British Approved Name (BAN), Pharmacopeial name, scientific name or description of the true nature of each of the active constituents. The use of British English names and spellings is required.

It may be required for umbrella Non-proprietary Name to be used for very specific scenarios, please consult with the Import Notification System team when required via imports@mhra.gov.uk . Common examples are included below:

• For homeopathic medicines, the following umbrella Non-proprietary Name should be used: HOMEOPATHIC INGREDIENT.

• For allergens, the following umbrella Non-proprietary Names should be used in the form depending on the product categories:

  • ALLERGENS IN SOLUTION FOR SKIN PRICK TESTING;
  • ALLERGENS IN SOLUTION FOR PATCH TESTING;
  • ALLERGENS FOR IMMUNOTHERAPY;
  • SUBLINGUAL IMMUNOTHERAPY (SLIT).

Proprietary Name (Brand Name)

The commercial brand name of the product. If there is none, you can leave this field empty or use the non-proprietary name.

When umbrella non-proprietary names are used in the non-proprietary name section of the form, the proprietary name section needs to be sufficiently specific to fully describe and identify the medicinal product. For example, by identifying which allergens or homeopathic ingredients are included in the product.

Strength and pharmaceutical form

The pharmaceutical dosage form of the product must be specified in full and abbreviations should be avoided.

The strength of the product must also be specified, including relevant units.

Examples: 40mg tablets; 20mg/mL solution for infusion

Pack Size

For unitary dosage forms this should be the total number of individual dosage forms in a single pack. For non-unitary dosage forms the total volume or mass of each of the containers should be provided.

Examples on what to write on the form:

Pack Size	Examples of what it may mean
1x30	pack with 30 tablets, 30 capsules, etc
30x2g	pack with 30 sachets of 2g each
1x2mL	pack with one vial or ampoule of 2mL
5x2mL	pack with five vials of 2mL each
1x30g	pack with one tube of 30g of cream, ointment, gel
3x30g	pack with three tubes of 30g of cream, ointment, gel

Special Clinical Need

A summary of the special clinical need. Evidence of the special clinical need may be needed separately as an attachment to the submission e-mail (for example, a signed clinical letter).