The Ministry of Health will evaluate the homeopathic products as if they were new, according to the draft of the royal decree on the registration of these substances in the Spanish Agency of Medicine that the department led by María Luisa Carcedo has prepared and is in the period of allegations. This implies that the fees they must pay are higher than if they were to review already registered and, therefore, already known and evaluated, despite the time they have been in the market.
The revision of the part of the royal decree 1345/2007 that affects the registration of homeopathic products is open to public consultation, whose term ends on the 16th of this month.
The registration of preparations for homeopathy is an obligatory step in Spain due to European regulation. The manufacturers have announced that they will present More than 2,000 products to register. Most will not indicate their use for a specific pathology, but in 12 if that type of record has been raised. The result is that they will have to pay much more.
The cause is that until now homeopathy is sold protected by a legal limbo. Although in 2007 it was established that they had to register, they did not, but they continued selling. The EU approved last year its use against the opinion of the representatives of Spain, but for this a period is given so that they register as they are the other products.
This procedure is essential for medicines, and has two modalities: a renewal of registration for drugs that had already been evaluated, or carry out a complete review, which is what is going to be requested from homeopathic products. This complicates your registration, and makes it more expensive. While for the revisions costs something more than 300 euros if the product does not have concrete allegations and 1,500 if it pretends to attribute them, for the new preparations the rates go from 600 to 8,600.
This decision is another of the conditions that the ministry, which has announced a plan against pseudotherapies collected in the General State Budgets that were presented yesterday, will impose on homeopathy after its defeat in Brussels. Another is the obligation to indicate on the packaging a warning that they do not have a scientific endorsement.