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Now please bear with me , I think my brain has hit its natural pdf reading overload, (PRO - apparently eased by vaping though not in any medicinal sense, at all, ever. )
I am using quotes from the Mhra - What is a medicinal product.
Apart from some usefull stuff (simplified for me). I was intrigued by the Statutory Procedure (pages 17 - 20 )
Quote
THE STATUTORY PROCEDURE
Provisional determinations
32. In all other cases where the MHRA is of the opinion that a product without a marketing
authorisation, a traditional herbal registration or a certificate of registration as homoeopathic
medicinal product and not otherwise exempt is a relevant medicinal product, the MHRA will
give notice by Special Delivery of its provisional determination, together with the reasons for
it. The notice will say that, if the company disagrees with the provisional determination, it
may make representations about it to an Independent Review Panel (“the Panel”). It will ask
the company for notice of any intention to make written or oral representations within four
weeks of the provisional determination. In the case of written representations, the
company will be expected to submit them to the Panel by a date not less than six weeks
from the date of the provisional determination. In the case of oral representations to the
Panel, the MHRA will, after consultation with the company, set a hearing date generally not
less than eleven weeks from the date of the provisional determination. In either case, there is
some scope to allow additional time for proper preparation of the company’s case.
Provisional determinations
32. In all other cases where the MHRA is of the opinion that a product without a marketing
authorisation, a traditional herbal registration or a certificate of registration as homoeopathic
medicinal product and not otherwise exempt is a relevant medicinal product, the MHRA will
give notice by Special Delivery of its provisional determination, together with the reasons for
it. The notice will say that, if the company disagrees with the provisional determination, it
may make representations about it to an Independent Review Panel (“the Panel”). It will ask
the company for notice of any intention to make written or oral representations within four
weeks of the provisional determination. In the case of written representations, the
company will be expected to submit them to the Panel by a date not less than six weeks
from the date of the provisional determination. In the case of oral representations to the
Panel, the MHRA will, after consultation with the company, set a hearing date generally not
less than eleven weeks from the date of the provisional determination. In either case, there is
some scope to allow additional time for proper preparation of the company’s case.
Quote
Final determinations if no representations are made
33. If no notice of intention to seek an oral hearing or submit representations is received
in time, or if the company asks to make representations but does not then do so, the MHRA
(acting as the Licensing Authority) will consider the product again, and make and issue a
final determination by Special Delivery, together with the reasons for it. If the product is
classified as a relevant medicinal product, the company will be reminded of the legal
provisions for the marketing of such products and what it needs to do to comply with them. It
will be asked to notify the MHRA of its compliance with the final determination within two
weeks. The MHRA also has power to issue a notice under regulation 3A(6) of the
Regulations, formally requiring the company to stop marketing the product, or not to place it
on the market, unless or until a marketing authorisation, a traditional herbal registration or a
certificate of registration as homoeopathic medicinal product has been granted in respect of
the product. Breach of such a notice is an offence under the Regulations, if the product is a
relevant medicinal product.
33. If no notice of intention to seek an oral hearing or submit representations is received
in time, or if the company asks to make representations but does not then do so, the MHRA
(acting as the Licensing Authority) will consider the product again, and make and issue a
final determination by Special Delivery, together with the reasons for it. If the product is
classified as a relevant medicinal product, the company will be reminded of the legal
provisions for the marketing of such products and what it needs to do to comply with them. It
will be asked to notify the MHRA of its compliance with the final determination within two
weeks. The MHRA also has power to issue a notice under regulation 3A(6) of the
Regulations, formally requiring the company to stop marketing the product, or not to place it
on the market, unless or until a marketing authorisation, a traditional herbal registration or a
certificate of registration as homoeopathic medicinal product has been granted in respect of
the product. Breach of such a notice is an offence under the Regulations, if the product is a
relevant medicinal product.
I have highlighted (or is it emboldened) the time scales. And if all the vendors simply ignore whats going on.
4 weeks + re consideration + 2 weeks
Cannot equal 21 days.
Or am I missing something ( most probably am, but cant see the wood for the trees atm. )
Ochso Kube
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