To the attention of interested persons
Given the current immunoglobulin crisis on the Romanian market and publication in the press of erroneous information about the application submitted by supplier Torus Pharma, in view of release of a special needs authorisation for human immunoglobulin, the NAMMD hereby states the following:
The initial application, submitted on 28.12.2017, was not compliant with the provisions of Order of the Minister of Health no. 85/2013 on approval of the Norms for implementation of provisions of Article 699 (1) and (2) of Law No. 95/2006 on healthcare reform concerning medicinal products for special needs, referring to, among others, the lack of medical justification issued by special commissions/directorates of the Ministry of Health, thus prompting the NAMMD to require supplementations in January 2018.
In the beginning of February 2018, supplier Torus Pharma sent supplementations to the authorisation dossier, on behalf of two Ministry of Health advisory commissions, which have highlighted the fact that the product, manufactured in India, has a composition „slightly inferior as opposed to that of similar products previously available on the pharmaceutical market, due to a smaller IgG and a bigger IgA content”.
Moreover, the NAMMD states that this category of medicinal products – blood or plasma-derived medicinal products – involves particular risks in terms of viral safety. Since the respective product is authorised in a non-EU country, rigorous manufacturing and control according to European standards cannot be ensured, as regards: the system of donor selection, authorisation of collecting centres, testing of individual donations, the standard of sensitivity of employed methods, their validation, the traceability system of donations until finished product, also involving maintenance of donation data for a 30-year period, viral safety trials conducted during the manufacturing process, with assessment of the ability of viral elimination/inactivation, etc. All these issues, detailed in the context of EMA guidelines which should be observed by blood-derived product manufacturers, are corroborated with the existence of a non-EU GMP certificate.
Considering the aforementioned issues, the NAMMD considers that the non-EU origin of the product cannot guarantee the safety and quality criteria imposed for EU products, and the authorisation for special needs does not allow, in this case (see Order of the Minister of Health no. 85/2013), neither sufficient assessment in terms of safety and quality of the plasma used in the manufacturing process, nor that of the product’s manufacturing process. Moreover, the NAMMD states that, in this case, a punctual testing of the finished product could not cover all previously mentioned aspects and could not fully guarantee the product’s quality.
The NAMMD wishes to assure its patients and the public that it strictly adheres to its mission to promote and protect public health by ensuring marketing of medicinal products compliant with top quality, safety and efficacy standards.