Ministerial Order SND/778/2023 of July, 10th
After months, Ministerial Order SND/778/2023 of July, 10th “Regulating certain aspects of the authorisation of industrially produced allergen-based medicinal products and bulk allergen-based medicinal products for human and veterinary use” has been published.
Allergens, both for human and veterinary use, are medicinal products and, therefore, are subject to the general regulation of these products, established both in national and European Union regulations, with the particularities foreseen therein, together with those established in this order. In addition to complementing the regulation corresponding to allergen-based medicinal products obtained through industrial production, which also includes those obtained by genetic engineering, this order establishes the particularities corresponding to the individualised preparation of allergen-based medicinal products for human and veterinary use.
At present, there are many allergen-based medicinal products that, although their production regime could be considered as industrially manufactured medicinal products, for various reasons, do not have the marketing authorisation for medicinal products as industrially manufactured medicinal products.
Likewise, due to the specific characteristics of the production of this type of medicinal products, some of the allergen-based medicinal products may have a mixed regime of industrial production in the early stages and individual packaging in the late stages.
Therefore, this Order seeks to establish a procedure that makes it possible to regularise the current situation of allergen-based medicinal products.
In the case of allergen-based medicinal products for in vivo diagnostic purposes for both human and veterinary use, they are considered to be industrially manufactured medicinal products, which means that they must obtain marketing authorisation in accordance with the provisions of Royal Decree 1345/2007 of 11 October, which regulates the procedure for the authorisation, registration and conditions of dispensing of industrially manufactured medicinal products for human use. For those allergen-based medicinal products for in vivo diagnostic purposes that are already on the market, it will be necessary for them to undergo a regularisation procedure in order to remain on the market. Therefore, it will be necessary that within 6 months the holders who are marketing this type of medicinal products send to the Spanish Agency of Medicines and Health Products (AEMPS) a detailed list of these (as established in Annex 1 of the Ministerial Order). For those medicinal products that have not been reported to the AEMPS after the 6-month period has expired, they must cease to be marketed, and no new batches of medicinal products may be placed on the market after that date.
In exceptional cases where the manufacture of allergen-based medicinal products for diagnostic purposes in vivo is specific to an individual patient or animal, the data relating to the medicinal product and the units used must be registered and kept at the disposal of the AEMPS for ten years from the date of manufacture, and the manufacture must be carried out in authorised facilities and in accordance with the rules of good manufacturing practice. The AEMPS must be informed of the start of production of medicinal products in this category.
In the case of bulk allergens, they must be authorised in accordance with the provisions of RD 1345/2007, with only module 1 being necessary for their evaluation, excluding the sections corresponding to the finished product, module 2, as regards quality data, excluding the finished product, and module 3, from which the sections corresponding to the finished product will be excluded. In turn, as with allergen-based medicinal products for in vivo diagnostic purposes, it will be necessary for those that are on the Spanish market and lack authorisation to undergo a regularisation procedure within 6 months in order to be able to continue on the market.
In the case of allergen-based medicinal products for immunotherapy, they must be authorised in accordance with the provisions of RD 1345/2007, for which it will be necessary to submit a marketing authorisation application accompanied by a complete dossier, and for those that are currently on the Spanish market and lack marketing authorisation, they must be submitted within 6 months to a regularisation procedure. For those allergen-based medicinal products for specific individualised immunotherapy, prepared from one or several industrially manufactured allergen bulks for a patient or animal, it will be necessary that they use authorised or registered allergen bulks, that the manufacture of these medicinal products is carried out in authorised facilities and in accordance with the rules of good manufacturing practice. And for those that are manufactured in isolation, it will be necessary that the information data of the medicinal product and the units used are registered and kept at the disposal of the AEMPS for 10 years from the date of manufacture, that the manufacture is carried out in authorised facilities and in accordance with the rules of correct manufacture, in turn, it will be necessary that at the time of the production of a medicinal product of this category it is communicated to the AEMPS.
An important aspect of this Ministerial Order is that the promotion or advertising of immunotherapy allergen-based medicinal products prepared from allergen bulk, or of immunotherapy allergen-based medicinal products manufactured in isolation, will not be allowed when these are intended for the treatment of a patient or animal.
At Azierta, our team of experts will be able to advise you and accompany laboratories with allergen-based medicinal products or bulk products in the submission of all the documentation requested by the AEMPS in order to comply with the new requirements within the deadlines established by the Ministerial Order.