In July 2013, after active lobbying by the Argentinian Association of Assistance to Celiacs, (ACELA) ANMAT decided to incorporate in the labeling texts of all drug products, information about their content of gluten.
Celiac disease is a condition that damages the lining of the small intestine and prevents it from absorbing parts of food that are important for staying healthy. The damage is due to a reaction to eating gluten, which is found in wheat, barley, rye, and possibly oats.
This new regulation, Disposición 2574/2013 defines ‘gluten-free’ products as those composed only by ingredients that, naturally or after purification, are free of protein from wheat, from all Triticum species, oats, barley and rye, and from their crossed species.
Gluten-free drug products, under all marketing conditions (OTC, Rx, etc.) must now include in their information leaflets and packaging labeling the claim: ‘Este medicamento es libre de gluten‘ (‘This drug product is gluten-free’) and the gluten-free symbol which is already being used for labeling of food products. (see image on the top) Both the claim and the symbol have to be easy to identify and read.
Marketing authorization holders must submit the analysis that verify the gluten-free condition and GMP certificates, to assure that the drug products are not contaminated with gluten. The analysis have to be performed on raw materials, intermediate and finished products, and the raw materials suppliers must submit an analysis protocol corresponding to the respective specifications.
All oral-dosage form drug products registered in ANMAT must comply with this new regulation within a year from the date of enforcement. (2nd May, 2013)
On the other hand, all registered oral-dosage form drug products that cannot prescind of gluten in their formula, have to justify its presence and quantify gluten per dosing unit. Within a year from the date of enforcement of this regulation, all theses drug products must include the following warning: ‘Este medicamento contiene gluten‘. (‘This drug product contains gluten’)
An antecedent to this resolution is an ICH specification (passed on to the USP, the European and the Japanese Pharmacopoeias) for wheat starch, restricting the content of total protein to o.3% in pharmaceutical products, thus reducing the level of gluten in this excipient.
As of October 2013, this regulation is still waiting for the relevant guidelines to be created, very necessary due to the difficulty of the implementation, especially of the testing of all products to guarantee they are gluten-free. Until the guidelines are issued, this regulation in on-hold and will not be enforced as initially intentioned.
Last update: October 2013
Regulatory Affairs in Latin America 