Frequently asked questions

PIP outcome documents published before exit day are available from the EMA website. PIP opinion documents published by the MHRA after exit day are available on the MHRA website here.

Search fields are dynamic and will auto populate with suggestive entries once you start typing. Simply select the entry that applies to your search from the dropdown list and the results will refresh in the tabular view below the search fields. You can narrow your search results by using the Active Substance field to search for a combination of Active Substances related to one PIP Number. You can widen your search through the use of the remaining search fields. Make sure to use the 'Reset Filter' feature if you wish to start over. 

To then view the details of the document, click on the hyperlink PIP Number and the full details will appear.

Yes, this can be done by clicking the ‘Download’ button found at the top right of your results.

Yes, when you click on the document hyperlink to display the full details of the PIP, you will be able to click on the hyperlink of the Opinion/Decision Document, open the PDF and download or print it from there.

After you have identified the PIP you wish to find more information on, click on the hyperlink that is presented in the column ‘PIP Number’, in the left-hand column of the results table. This link will bring you to the ‘Key Facts’ page.

Yes, you can search for records between certain dates or based on the start or end date. To do so look to the bottom of the search fields to ‘Date Published’. Input the specific dates you wish to search for.  

It can take 2 days for your Authorisation or Certificate to appear in MHRA-GMDP. If this is not the case, then please contact info@mhra.gov.uk for assistance, giving as much information as possible to help the team answer your query.

Yes, this can be done by clicking on the Download button found at the top right of the results.

If you feel that the information on the system is incorrect, then please contact info@mhra.gov.uk for assistance. This could be the company name, address, site functions, dates or other details. Please give as much information as possible to help the team investigate the discrepancy.

Please allow 2 working days from when your document was issued to then appear on the MHRA-GMDP system. If after this time period has elapsed it is still not present, please contact info@mhra.gov.uk for assistance, giving as much information as possible to help the team answer your query.

In order to wholesale distribute medicinal products organizations must be in possession of a wholesale dealers authorization and fulfil certain obligations, one of which is to comply with the principles and guidelines of good distribution practice. When medicinal products are supplied or received a check to ensure the appropriate authorization is held needs to be performed. In addition where medicinal products are received from another wholesaler the receiving wholesaler must verify that the supplier complies with the principles and guidelines of good distribution practice. Part of this check is to ascertain if the supplier holds a GDP certificate

MHRA endeavor to perform re-inspections in advance of the validity date of the GDP certificate in order to ensure continuity of the documentation. However due to the risk based prioritization of resources this is not always possible and we are aware that some GDP certificates have now passed their validity date.

Where a sites GDP certificate has passed its validity date wholesalers should continue to perform their own checks to assure themselves that an appropriate authorization is held and the principles and GDP guidelines are being adhered to.

Checks to verify the supplier complies with GDP could include:

1. If they have more than one site, then reference to GDP certificates issued to other sites more recently

2. For established suppliers, a review of deviations / complaints / damages / returns records relating to the supplier

3. For new suppliers a declaration of GDP compliance provided by the RP

4. Evidence that a recent inspection has taken place which has yet to generate a new certificate.

Yes, when you click on the document hyperlink to display the full details of the Authorisation/Certificate a download PDF button will be visible. Click the download PDF button and the document will be converted to pdf which will then allow you to print. This will be watermarked ‘MHRA-GMDP’ to make it clear that it’s a copy of the original document.

When searching within MHRA-GMDP there is no specific search button to select. Instead, the search fields displayed are dynamic and will auto populate with suggestions once you start to type information into them. For example, if you type 999 into the Authorisation Number field the available entries will appear as a drop down.

When you are ready to see the results of the search, simply click out of the search field and the query will then run, and the results refreshed below.

To then view the details of the document, click on the hyperlink and the full details will appear.

When carrying out a search, the results are refreshed in the table below.

It is then possible to carry out a further search without losing the results of the previous search. To do this, proceed to perform a further search without clicking the ‘Reset Filter’ button.

This will then mean that the second set of results will appear alongside the 1^st query results allowing you to see your 2 results together on the same screen. You can repeat this process to add further results.

For queries concerning the information displayed in MHRA-GMDP please contact info@mhra.gov.uk for assistance, giving as much information as possible to help the team answer your query.

If you feel that the information on the system is incorrect, then please contact tpdnotifications@mhra.gov.uk for assistance. Please give as much information as possible to help the team investigate the discrepancy.

To supply an E-cigarette device or Nicotine containing liquid product in the UK a manufacturer must notify their products to the MHRA for Great Britain and Northern Ireland. Once the product has been assessed and published on the relevant list then the product is legal for supply.

Detailed information and guidance on E-cigarette products can be found on our main MHRA page here.

Reporting an adverse reaction via Yellow Card

If you feel unwell after using an e-cigarettes product you can report side effects and safety concerns with e-cigarettes or refill containers to the MHRA through the Yellow Card scheme.

If you would like to provide information about the sale of defective, non-compliant or illegal e-cigarette products you can contact the MHRA at TPDsafety@mhra.gov.uk, alternatively you can contact Trading Standards.

Once you have made a search query, a 'Reset Filter' button will appear. Click on this to reset your search query to start over.

The product may have been published prior to January 2021 and may appear in one of the links provided on the main publication page. If the product you are looking for is not published, it cannot be legally suppled in the UK.

Previously notified are still legal for supply and published. Details of these products will appear in the historic links available on the main publication page.

To download the excel file, Click on the respective link under the Excel to Download column.

Search fields are dynamic and will auto populate with suggestive entries once you start typing. Simply select the entry that applies to your search from the dropdown list and the results will refresh in the tabular view below the search fields. You can narrow your search results by using the Submitter Name field to search for a combination of Submitter Name related to one ECID/GBID. You can widen your search through the use of the remaining search fields. Make sure to use the 'Reset Filter' feature if you wish to start over. 

For queries concerning the information displayed in the PSUR publishing portal please contact Pharmacovigilanceservice@mhra.gov.uk for assistance, giving as much information as possible to help the team answer your query.

Search fields are dynamic and will auto populate with suggestive entries once you start typing. Simply select the entry that applies to your search from the dropdown list and the results will refresh in the tabular view below the search fields. You can narrow your search results by using the Active Substance field to search for a combination of Active Substances related to one Procedure Number. You can widen your search through the use of the remaining search fields. Make sure to use the 'Reset Filter' feature if you wish to start over. 

To then view the details of the document, click on the hyperlink in the ‘Outcome Document’ column to open the Outcome Document PDF.

Yes, you can search for records between certain dates and based on the start or end date. To do so look to the bottom of the search fields at ‘Date Published’. Input the specific dates you wish to search for, remembering to put them in the correct order.

After you have identified the item you want to seek further information on, click on the hyperlink that is presented as the ‘Outcome Document’, in the left-hand column of the results table.