Freedom of Information request on information regarding Panadol Extra Soluble Tablets (FOI 22/747)
Published 21 December 2023
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FOI 22/747
4th July 2022
Dear
Thank you for your communication, dated 06 June 2022, in which you requested the following information relating to Panadol Extra Soluble Tablets (effervescent tablets, PL 44673/0077).
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Confirmation that the product is acceptable as the Reference Product, i.e., the MA is registered under the Article 8 (3) of Directive 2001/83/EC. Alternatively under the Article 10a or Article 10b (fixed-combination medicinal products) of Directive 2001/83/EC.
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The assessment report from 1991 for Panadol Extra Soluble tablets
Panadol Extra Soluble Tablets (PL 44673/0077; GlaxoSmithKline Consumer Healthcare (UK) Trading Limited) was granted a Marketing Authorisation on 22 March 2016, following a change of ownership from PL 00071/0379, which was granted a Marketing Authorisation to Sterling-Winthrop Group (SWG) Limited on 23 August 1991. The Marketing Authorisation for PL 00071/0379 was granted according to Article 4.8(a)(i) of Directive 65/65/EEC (as amended), referring to Panadol Extra Tablets (PL 00071/0306) which was granted to Sterling-Winthrop Group Limited on 26 May 1988.
We are unable to confirm the legal basis of the Marketing Authorisation for Panadol Extra Tablets (PL00071/0306), due to the age of the product licence. However, we consider it to be a full dossier product, and can be cited as a regulatory reference product (RP1) and comparator product (Reference product 2 and Reference product 3) in support of a marketing authorisation application for Paracetamol/Caffeine 500 mg/65 mg Tablets.
Also, Panadol Extra Soluble Tablets (PL 44673/0077) belongs to the same Global Marketing Authorisation as Panadol Extra Tablets (PL 44673/0087), and can be cited as comparator product (Reference Product 2 and Reference Product 3) in support of a marketing authorisation application for Paracetamol/Caffeine 500 mg/65mg Soluble Tablets.
Despite a thorough search of our electronic records, including a search for the product in our database which details what we hold in the paper archives, we have been unable to locate any assessment reports for PL 00071/0379.
We now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at [email protected]
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]
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Yours sincerely
MHRA Customer Experience Centre