New guidelines of the European Commission regarding the safety of medicinal products and medical devices
Identification of medical devices and of medicinal products subject to additional monitoring
CAPSULAS Nº 142
Regulation (EU) No 198/2013 regarding the new identification symbol that must be incorporated by medicinal products whose authorization is subject to additional monitoring was published this past March. This publication was followed, only a month later, by the Commission Recommendation of 5 April 2013, through which a unique device identification system is intended to be... Read More
New guidelines on the labelling of food products that claim beneficial properties for health
Decision of the Commission, of 24 of January of 2013, with guidelines on the application of Regulation (EC) No 1924/2006 on nutrition and health claims
Background Food products claiming beneficial properties for health represent an increasingly more attractive market. Their proliferation over the last two decades lead the Community authorities to regulate their advertising through Regulation (EC) 1924/2006, with the objective to adequately protect consumers while putting an end to the disparity of criteria that national authorities had been applying... Read More
Novelties in the fight against late payment of debts of companies and Public Administrations: one step forward and another one back
Royal Decree-Law 4/2013, of 22 of February, on support measures for entrepreneur, stimulation of growth and job creation
CAPSULAS Nº 141
On 23 of February Royal Decree-Law 4/2013 was published in the Official Journal. In spite of its title, such regulation amends various fields that have little or nothing to do with employment. We refer here to the amendments that affect Law 3/2004, which establishes measures for fighting late payment in commercial transactions, and the recast... Read More
It is necessary to verify the safety of the product in order to be exempt from liabilities
Judgment of the Provincial Court of Madrid, Section 8, number 589/2012, of 29 of October of 2012
CAPSULAS Nº 140
Background The Provincial Court of Madrid (APM) has issued a judgment on civil liability for defective product that examines one of the cases foreseen by law to exempt the manufacturer or importer of the product from liability even if the defect, the damage and the causal relationship between these two elements have been proven. The... Read More
The importance of not making a mistake with the envelope when submitting an offer in a public procurement proceeding
Case 9/2012, of 4 of December, of the Consultative Commission of Public Procurement of the Board of Andalusia
CAPSULAS Nº 140
Background An Andalusian city council called a procurement procedure for the management of home assistance, through an open procedure and based on several awarding criteria. In their offers the bidders had to submit the criteria to be valued through formulas (the software and the economic offer) in envelope B and the criteria to be considered... Read More
Competition law, to the defense of those who bear the cost of healthcare services
Resolution of the Council of the Spanish Competition Authority of 9 of January of 2013, Case S/0299/10, Council of Professional Odontologists and Stomatologists Associations
CAPSULAS Nº 140
In this Resolution, the Spanish Competition Authority (CNC for its acronym in Spanish) declares that the Council of Professional Odontologists and Stomatologists Associations of Spain has infringed the Spanish Competition Law 15/2007, for carrying out acts that entail that dentists get to impose the choice of the dental prosthetics. An analysis of the Resolution reveals... Read More
Strict implementation of the terms to request reimbursement of fees. It is important to pay attention to them in order not to lose money
Judgment of the National High Court, of 14 and 17 of January of 2013, on reimbursement of fees for applications to the AEMPS
CAPSULAS Nº 140
These are difficult times for everyone and healthcare administrations are no exception. The containment of the deficit imposed by our European partners makes us scrutinize every euro that we spend, and an example of this would be the tightening of the criteria applied by the AEMPS for the access to the reimbursement of the fees... Read More
News regarding prescriptions in Spain and in Europe: more guarantees for the patient, especially in the case of biological medicinal products
During the year 2013 Royal Decree 1718/2010, of 17 of December and Directive 2012/52/EU of the Commission shall come into force
CAPSULAS Nº 139
Private prescriptions Royal Decree 1718/2010, of 17 of December, regarding medical prescriptions and dispensation orders requires that starting from 21 of January of 2013 private prescriptions, both in paper as well as in electronic form, must have a homogeneous content and format in the entire territory of Spain. The regulation details the data that will... Read More
Competition rules and liberalization of activities in the pharmaceutical sector
Regarding the Report of the Spanish Competition Authority (CNC) on the draft Royal Decree on distribution of medicinal products
CAPSULAS Nº 139
Recently, the CNC has issued its report on the Draft Royal Decree on Distribution of Medicinal Products for Human Use. The publication of this report coincides in time with the completion of the Draft Royal Decree on financing and pricing of medicinal products and with the appearance of news about the reopening of the debate... Read More
Regulations applicable to medical devices apply when the device is intended for medical purposes
Judgment of the European Court of Justice (ECJ) of 22 November 2012, Case C-219/11 Brain Products
CAPSULAS Nº 139
Background In this Judgment the European Court of Justice has expressed its position on the interpretation of the definition of “medical device”, in a reference for a preliminary ruling from a German Court, in the proceedings between Brain Products and BioSemi. The dispute between the above mentioned companies occurred in connection with BioSemi’s marketing of... Read More