COLOMBIA | Regulatory | Coding changes in pharma regulations
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From June 1 2016, Marketing approval (MA) applications for pharmaceuticals and the importation authorization of vital medicines not available in Colombia (totally or partially) –MVND in Spanish- must comply with the corresponding identification code –or IUM in Spanish- for each commercial form.
This decision fulfills the standard requirements for pharmaceuticals set by Resolution 3166 (2015), which indicates the IUM should allow the link between the common description of the pharmaceutical and the commercial form of the medicine.
Decree 843 of 2016 also provides changes related to the renewal and modification of MAs related to chemical synthesis and medical gases pharmaceuticals. Starting from 20 June 2016, the Colombian Regulatory Authority (INVIMA) will automatically renew the MAs and then perform the review of requirements.
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COLOMBIA | Regulatory | INVIMA introduces modifications to food marketing approval forms
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The changes were made for forms related to (i) applications, (ii) permissions and (iii) food sanitary notifications before the INVIMA, and its use is mandatory after 1 June 2016.
The new forms can be found here.
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ARGENTINA | Intellectual Property | Shift towards intellectual property: Argentina could enter into The Pacific Alliance trade bloc
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The Argentinian chancellor, Susana Malcorra, hinted that Argentina will participate as an observer in the XI Pacific Alliance Summit, which will be held on 1 July 2016.
This shows Mauricio Macri’s Government interest in changing the Argentinian trade and economic policies towards economic openness, contrary to the last Argentinian government policies. This, inherently, translates into a more prosperous environment for intellectual property in Argentina, which has been considered as unfavorable in some analysis such as the USTR Special 301 Report-.
The Pacific Alliance currently has four members: Chile, Colombia, Mexico and Peru.
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COLOMBIA | Intellectual Property | Colciencias signs agreement with Cundinamarca Department to boost I+D investments
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On 27 May 2016, the Colombian Administrative Department of Science, Technology and Innovation (Colciencias in Spanish) and the Department of Cundinamarca signed a Departmental Plan and Agreement in science, technology and innovation, which will provide investments exceeding USD $ 30 million for the next 4 years in the region.
The program is aimed to promote scientific projects in health, agriculture and renewable energy fields, and will encourage the involvement of universities and private sector.
The funds will come from the Science, Technology and Innovation Fund of the Colombian General Royalties System, being an initiative which will contribute to achieve in 2019 a Gross Domestic Product investment exceeding 1% in science, technology and innovation.
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COLOMBIA | Regulatory | Law approving Cannabis use for medical purposes: at only one step of entry into force
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On 25 May 2016, in its last debate, the plenary of the Colombian Parliament House of Representatives Chamber approved the Bill which regulates the crop and use of Cannabis, its derivatives and the products containing it for medical and scientific purposes.
The Bill is in conciliation and is about to be sanctioned by the president. This law is additional to Decree 2467 of 2015 (included in the new Health Regulation Decree -780/2016-) and Regulation 1816/2016, which regulates the procedures to crop, manufacture and exportation licenses of Cannabis for medical and scientific purposes.
You can see the last available Bill text here. The next links (one and two) show the issuing process history.
