CHEMICAL IMBALANCE - PATIENT INFORMATION LEAFLETS FOIA TO MHRA

 

For the record, I emailed the MHRA earlier with the following request:

To whom it may concern,

According to UK legislation, [Regulation 267 of the Human Medicines Regulations 2012] it requires that marketing authorisation holders (MAH) of UK MAs and article 126a authorisations inform the competent authority of all changes to the labelling and patient information leaflets which are not connected with changes to the Summary of Product Characteristics (SmPC).

With this in mind, I hereby request the following information:

1. When did the marketing authorisation holders (MAH) of citalopram change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

2. When did the marketing authorisation holders (MAH) of escitalopram change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

3. When did the marketing authorisation holders (MAH) of fluoxetine change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

4. When did the marketing authorisation holders (MAH) of paroxetine change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

5. When did the marketing authorisation holders (MAH) of sertraline change the labelling and patient information leaflets with regard to any reference referring to a "chemical imbalance" and what was the reason/evidence for this change.

Sincerely,

Bob Fiddaman