Frequently asked questions

PIP FAQ

  1. Where can I find my PIP opinion/decision document?

    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.

  2. How do I use search filters?

    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. 

    search filters

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

    full details

     

  3. Can I export my search results into Excel?

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

    export Excel

     

  4. How can I see the Key Facts of a PIP?

    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.

    Key Facts

     

  5. Can I print a copy of my Opinion/Decision document?

    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.

    Opinion/Decision document

     

     

  6. Can I search records within specific dates?

    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.  

    specific dates

     

  7. How do I clear my search?
    Once you have made a search query, a 'Reset Filter' button will appear. Click on this to reset your search query to start over.
    clear search

     

MHRA-GMDP FAQ

  1. MHRA GMDP FAQ header

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

  2. Why are there expired GDP Certificates on the system?

    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.

  3. I cannot find my Authorisation/Certificate in MHRA-GMDP

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

  4. Can I export my search results into Excel?

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

    export Excel

    (This information does not reflect the live system, for illustrative purposes only)
  5. Why is our information incorrect on the system?

    If you feel that the information on the system is incorrect, then please contact IE&S-IMT@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.

  6. Our Authorisation/Certificate was issued today, but MHRA-GMDP does not reflect this

    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 IE&S-IMT@mhra.gov.uk for assistance, giving as much information as possible to help the team answer your query.

  7. Can I print a copy of an Authorisation/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.

  8. How do I search for an Authorisation/Certificate?

    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.

    Authorisation/Certificate

    (This information does not reflect the live system, for illustrative purposes only)

    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.

    results refreshed

    (This information does not reflect the live system, for illustrative purposes only)

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

    view document

    (This information does not reflect the live system, for illustrative purposes only)
  9. How can I display multiple search results on one screen?

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

     

    multiple search

    (This information does not reflect the live system, for illustrative purposes only)

    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. Reset Filter

    (This information does not reflect the live system, for illustrative purposes only)

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

PSUR FAQ

  1. PSUR FAQ header

    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.

  2. How do I search for a PSUR outcome?

    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. 

    PSUR outcome

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

    Outcome Document

     

  3. Can I search records within specific dates?

    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.

    search records

     

  4. How do I view the PSUR Outcome Document?

    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.

    PSUR Outcome Document

     

ECIG FAQ

  1. How do I use search filters?

    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. 

    search filter

     

  2. How do I know if an E-cigarette product is legal in the UK?

    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.

  3. What should I do if the product I am looking for is not published?

    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.

    Ecig

     

  4. How do I report an E-cigarette product?

    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.

  5. Where can I find more information?

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

  6. Are products notified via the EU before Jan 2021 still be valid 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.

    Ecig

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

    Ecig

     

  7. Why is our information incorrect on the system?

    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.

  8. How do I clear my search?

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

    Clear Search