INFO KGV | LIFE SCIENCES APRIL 2019
PRICES FOR OTC DRUGS DEREGULATED
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Leonardo Barboni Rosa, Kestener Granja e Vieira Advogados
On 26 March 2019, the Brazilian Drug Market Regulation Chamber (CMED) published Resolution No. 2/2019 (Portuguese Language), which deregulates the pricing of over-the-counter (OTC) drugs, herbal drugs and local dental anaesthetics.
According to the Resolution, the transfer from the current regime, under which maximum bulk and retail prices are fixed by CMED, to a new regime where prices will be solely and freely set by the market, shall happen gradually.
In the first phase, only herbal drugs, homeopathic drugs and drugs subject to simplified notification will be exempt from price regulation (CMED Notice No. 4/2019 (Portuguese language)). CMED may exempt other kinds of drugs in the future.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
ANVISA PROPOSES SIMPLIFIED REQUIREMENTS FOR LOW COMPLEX BIOLOGICS
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Giovanna Pasquini Malfatti, Kestener Granja e Vieira Advogados
On 29 March 2019, the Brazilian Health Surveillance Agency (ANVISA) published Public Consultation No. 633/2019 (Portuguese Language), regarding the procedure and requirements for the registration of low complex biologics.
Currently, the registration of biological drugs is subject to Resolution RDC No. 55/2010 (Portuguese Language). Although the requirements established in this Resolution are suitable for the majority of biological drugs, some are considered excessive for “low complex biologics”, for example, lactase and collagenase supplements, which are biologics that do not have a complex molecular structure. The public consultation proposes a resolution that aims to simplify the registration procedure for these simpler drugs.
Contributions to the consultation may be submitted until 3 June 2019, on ANVISA’s website (Portuguese Language).
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
NEW RULES FOR SANITARY LICENSING OF PHARMACIES AND DRUGSTORES
Beatriz M.A. Camargo Kestener, Rubens Granja, Natássia Misae Ueno, César Santos Borlina and Leonardo Barboni Rosa, Kestener Granja e Vieira Advogados
On 10 April 2019, the Brazilian Health Surveillance Agency (ANVISA) published Resolution RDC No. 275/2019 (Portuguese language), which updates the sanitary licensing procedure for pharmacies and drugstores. The procedure was previously regulated by Resolution RDC No. 17/2013, which has now been revoked.
The main change concerns the sanitary licence validity term. Previously, companies were required to make an annual request to renew their licence. Now, the licence’s validity term is indefinite. The establishment must continuously comply with the requirements associated with the licence, which shall be regularly inspected by State and/or Municipal authorities.
Another important update concerns the deadline for ANVISA to issue a decision in response to a licence request. Under the new Resolution, if ANVISA does not issue a decision on a request within 30 days, the licence shall be automatically granted.
“Reproduced from Practical Law with the permission of the publishers. For further information visit www.practicallaw.com or call +44 (0)20 7542 6664.”
