“CE” MARKED ON MOBILE APPLICATIONS

Nowadays the use of Smartphones and tablets are very common for the medical sector to inform patients. Diagnostics, treatments and follow-ups are revolutionizing the medical and patient relationship in many disciplines such as diets.

In the European framework, devices and applications that we have mentioned must meet the requirements of directives and regulations for medical devices. In this case, it is mandatory to have the health product manufacturer’s license, granted by the Agencia Española de Medicamentos y Productos Sanitarios. (AEMPS) Read more

EXTENSION OF THE SUITABILITY TERM OF LABELING AND INSTRUCTIONS FOR USE OF SANITARY PRODUCT AS A CONSEQUENCE OF BREXIT

“AEMPS extends the deadlines until May 25, 2021 for the adequacy of the labeling and instructions for use of health products as a result of the changes made by Brexit.”

 

On February 1, 2020, the United Kingdom ceased to be considered a Member State of the EU to become a third country, as stated in the Withdrawal Agreement, ratified by the European Parliament.

From this date a transition period comes into force which will last until next December 31st allowing, for practical purposes, everything to remain the same for health product companies in both the European Union and the United Kingdom.

In November 2019, the informative note PS, 29/2019 was published establishing a deadline until June 30, 2020 for the adequacy of the labeling and instructions for use of health products as a result of the changes made as a result of Brexit.

Faced with the difficulty that this change is posing to companies and considering the consequences derived from the COVID-19 pandemic, which may have hindered its implementation, the AEMPS has considered extending the deadline until May 25, 2021, in order for the companies that are in this situation to finalize the adaptation of the labels and the instructions for use of the products to the changes made.

All relevant information is updated and developed in detail on the AEMPS website.

 

Article Source: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

 

 

LABELING AND SAFETY INSTRUCTIONS FOR THE USE AND STORAGE OF HYDROALCOHOLIC GELS AND SOLUTIONS

  • Gels and hydroalcoholic solutions, because they have a high percentage of ethanol, are flammable.
  • If they are biocidal in nature, they must include in their labeling the risks in an easily identifiable way and advice on how to use them.
  • If they are cosmetics, the percentage of alcohol can be variable, but it is recommended to follow the same precautions regarding the use of the product.
  • AEMPS publishes a series of tips for using and storing them properly.

 

Biocides must include in their labeling the “CLP” classification in accordance with Regulation 1272/2008 if any of their ingredients or a mixture can be classified as dangerous and what are the indications and advice to be taken to avoid risks

This happens in the case of hydroalcoholic gels/solutions of a biocidal nature since they contain ethanol in most of their composition. For this reason, their labeling must include an easily identifiable pictogram indicating that they can be dangerous and that they are flammable. In addition, they must establish a series of indications of the nature of the risk and advice for use and conservation. Also because of this high ethanol content, they can cause serious eye irritation and are toxic if ingested.

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Hydroalcoholic gels/solutions of a cosmetic nature may contain a very variable amount of alcohol and are not required to include this information on the labelling. However, the AEMPS recommends that the same precautions be followed as with gels and hydroalcoholic solutions of a biocidal nature, and for this reason it has drawn up a series of tips to handle them correctly and to be able to take the appropriate precautions for their preservation.

 

  • Avoid applying gels and hydroalcoholic solutions to sensitive or damaged areas of the skin or mucous membranes.
  • Always keep gels and hydroalcoholic solutions away from heat sources such as hot surfaces, direct sunlight, open flames, sparks or any source of ignition.
  • Avoid smoking immediately after using these gels or solutions or in places where they are stored.
  • Store it in a well-ventilated and cool place, avoiding spaces where significant temperature changes occur.
  • In case of contact with the eyes, rinse them with plenty of water for several minutes. If irritation persists, consult a doctor.
  • In case of ingestion, immediately call the Poison Control Service or go to an emergency doctor.

 

Article source: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). (https://www.aemps.gob.es/)

 

 

NEW STANDARD FOR FABRIC MATERIALS FOR SANITARY PRODUCTS

The current health crisis caused by COVID-19 has generated the need for mass production of medical and health products, and especially masks.

These products are mainly made with non-woven fabrics as they are materials that have no known risks of irritation or adverse health effects. They are hypoallergenic, biocompatible and harmless, breathable and repel liquids and fluids. In addition, independently or combined with other materials, they provide high protection against infections and diseases.

As for these fabrics, the Asociación Española de Normalización , UNE, has published the standard UNE-EN ISO 9092:2020 Nonowen. Vocabulary, revision of the old version which only included the definition of the term Nonwoven.

In this new standard, the object and the field of application have been extended to also include auxiliary terminology to distinguish non-wovens from other materials.

This rule has been drawn up by the CTN 40 Textile Industries, whose Secretariat is CIE .

News source: www.une.org

AEMPS INFORMS ON THE USUAL PROCEDURE FOR IMPORTING HEALTHCARE PRODUCTS