OM Weekly Digest (16-09-2016)
September 16 2016


ARGENTINA | Regulatory | Argentina removes presentation of costs structure in “highly complex” medicines


The requirement was removed on 5 September 2016, by means of Joint Resolution 1 of 2016, and was required to pharmaceuticals companies, which before that date had to present the cost structure of its high complexity medicines.

The decision repeals Articles 3, 4 and 5 of the Joint Resolutions 1710 and 406 of 2015 from the Ministry of Health, which required that pharmaceuticals of high economic impact for the Argentine health system justify its final sales price.

It is worth mentioning that the new resolution remains the validity of Joint Resolutions 1710 and 406 Articles favoring pharmaceuticals produced in Argentina.  In those articles, is stated that the final selling price of pharmaceuticals manufactured in the country should be “significantly lower” that imported products with similar characteristics.


ARGENTINA | Regulatory | Regulatory Authority of Argentina starts a program for the development of policies in over-the-counter pharmaceuticals


On 31 August 2016, and by means of Disposition 9807 of 2016, the ANMAT (Argentina’s Regulatory Authority) establishes an “Over-the-counter Medical Specialties Program”.

The program aims the development of policies on OTC pharmaceuticals. Among its functions, it will design qualitative and quantitative studies on these drugs and its market.

As a result of that program, in the future is expected a change in OTC pharmaceuticals labels and descriptions and in the form of advertising of them. This, in order that consumers use them correctly.


UNITED STATES | Regulatory | FDA bans the use of 19 antiseptics for antibacterial soaps


On 2 September 2016, the U.S. Food & Drug Administration (FDA) issued a final rule banning commercialization of antibacterial soaps containing certain active ingredients.

The decision was motivated by the lack of evidence to show that its long-term use is safer and effective versus plain soap and water in preventing of illness.

Manufactures will have one year from the issuance of the new FDA regulation to comply with the rule. For more information and to know the full list of banned antiseptics (including triclosan, triclocarban, iodine complexes and povidone-iodine 5 to 10%, also available in the final rule) you can access the following link.


EUROPEAN UNION | Trademarks | Reminder: until 24 September 2016 it’s possible to adapt trademark registrations to the latest version of the Nice Classification


On 16 March 2016 the Regulation (UE) number 2015/2424 came into force, this introduces changes in relation to the applied rates, technical issues and institutions.

One of the most important topics is related to the Nice Classification and its importance in trademark registration al filling around the different versions that have emerged over the years; in consequence was granted to the trademarks filled before 22 June, 2012 a grace period until 24 September, 2016 where the trademark holders a registered with past Nice Classification versions may be able to express though a document that his initial intention was to identify products/services beyond those listed in the classification of the time but which today are included in the latest version of the Nice classification.

For more information about the changes click here.


COLOMBIA | Consumer Law | The sale of laser pointers is prohibited in Colombia


Further to the OM Weekly Digest of 9 June 2016, on 29 August 2016 and with the issuance of Resolution 57151 of 2016, the Colombian Consumer Law Authority (Superintendence of Industry and Commerce –SIC-) definitively prohibits the sale of laser pointers exceeding 1 milliwatt (mW), in order to protect consumers.

Now, the sale of laser pointers with that power will be permitted only for medical, scientific, industrial and military purposes. A register kept by authorized dealers shall certify the use of lasers in these areas.

Additionally, the use of any type of laser in public gatherings is also prohibited, in order to prevent incidents that threaten the health of consumers.