The Spanish Agency of Medicines and Health Products (AEMPS) has ordered the withdrawal of 66 homeopathic products with therapeutic indication or whose route of administration is injectable for not having provided the corresponding documentation for authorization.
A total of 66 homeopathic products have been withdrawn for not presenting the required documentation for authorization, as stated in the Royal Decree 1345/2007, of October 11.
These products are, according to the schedule set by the standard, within the first cycle of evaluation, which ended on April 30 and which covered the dossiers of the products with therapeutic indication and those without therapeutic indication whose route of administration is injectable The products within this group that have submitted the documentation are in the first evaluation process by the AEMPS. When finalizing said evaluation will be when it is determined if they are authorized and, in his case, the conditions of prescription of this type of products and when they must include in the cardboard and prospect the legends that allow the correct identification of the same.
On April 30, the AEMPS announced the publication of the Ministerial order that determined the minimum requirements and the procedure for the homeopathic products covered by the transitory provision six of the Royal Decree 1345/2007, of October 11 , will be adapted to the registry as foreseen in the Directive 2001/83 / EC of the European Parliament and of the Council, of November 6, 2001.
The publication opened a deadline for holders of homeopathic products to inform AEMPS of its intention to adapt to the provisions of the aforementioned Royal Decree.
Once that period was over, the AEMPS published the resolution that establishes the list of homeopathic products communicated and set the schedule for the holders to request the corresponding marketing authorization. Only the homeopathic products that are included in this resolution may continue to be marketed until their evaluation and subsequent decision. The rest of homeopathic products can not continue to be commercialized and, therefore, those that are in pharmacies have been withdrawn. In this resolution, a total of 2,008 products were published.
It is important to note that the products included in this resolution are not products authorized by the AEMPS. The resolution allows the products that are still marketed under the sixth transitory provision of Royal Decree 1345/2007, of October 11, until its evaluation occurs and the authorization is resolved. If it were resolved not to authorize, the denied products would have to leave the market. Likewise, if the period for the presentation of the dossiers has ended, the owner would not have presented it, the product will no longer be immediately covered by the aforementioned sixth transitory provision and must leave the market.
In accordance with the schedule set, six cycles of presentation of dossiers and evaluation have been established. The first cycle will cover the request of the files requested with therapeutic indication (they will be evaluated as the rest of the medicines following the same scientific principles) and those without therapeutic indication whose route of administration is injectable. In the established period, which ended on April 30, the holders had to present the dossiers in electronic format (eCTD) with the corresponding documentation that endorses the possible authorization of their products according to the two existing legal bases (for products claiming or not a therapeutic indication).
As the calendar is fulfilled, the AEMPS website will be updated with all the information about it and the list of all the homeopathic products that it affects.