- This topic has 2 replies, 3 voices, and was last updated 1 year, 5 months ago by .
- You must be logged in to reply to this topic.
Home › Forums › Pharmacovigilance Forum › Patient Identifiers vs valid reports – MHRA
Hello!
One question regarding patient IDs for a valid report in the UK.
As you will be aware of, EMA has a stricter approach than the FDA regarding patient IDs for a valid report:
– while FDA considers a define # of patients to be sufficient proof that a patient exists (even if no other patient IDS like name initials, DOB, gender etc are available); EMA considers only reports to be valid if a standard patient ID is gathered.
There was a question regarding this on our case processing team (based in the US) – after Brexit, does the MHRA align fully with the EMA regulations on this respect, or are they open to receive reports where just “a patient”; “3 patients” etc are identified? I do believe the Human Medicine Regulations fully align with the EMA on this respect, but wanted to gather others’ perspectives.
Thank you!
hi, I have the same question,
as per GVP module ,
” identifiable ” refers to the possibility of verification of the existence of a patient based on the available information.
Hi,
As per the guidance v2 “Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority” released by the MHRA, there is no modification to the term identifiable patient. So the GVP module definition of identifiable patient applies for UK as well.
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
Cookie | Duration | Description |
---|---|---|
cookielawinfo-checkbox-analytics | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics". |
cookielawinfo-checkbox-functional | 11 months | The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". |
cookielawinfo-checkbox-necessary | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". |
cookielawinfo-checkbox-others | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. |
cookielawinfo-checkbox-performance | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". |
viewed_cookie_policy | 11 months | The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data. |
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.