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DOUE cambioslegales.es › European Regulations

Correction of the European regulation on quality management for notified bodies of medical devices

10 Jun 2026 5/10 European Regulations Effective: 05/05/2026

The European regulation establishing quality requirements for bodies certifying medical devices and in vitro diagnostic products is corrected. It affects notified entities that assess the conformity of these products in ...

Notified bodies, manufacturers of medical devices and in vitro diagnostic devices in the EU
DOUE cambioslegales.es › European Regulations

New protein requirements in infant formula made with protein hydrolysates

09 Jun 2026 5/10 European Regulations

The rules on protein content of infant and follow-on formulae manufactured with protein hydrolysates are updated, adapting requirements to current scientific evidence.

Manufacturers and distributors of infant formula in the EU
BOE cambioslegales.es › Other Regulations

SMS Blocking for Unregistered Aliases Delayed Until September 2026

05 Jun 2026 5/10 Other Regulations Effective: 06/06/2026

The deadline for operators to block SMS messages with unregistered aliases has been extended from June 7 to September 15, 2026 due to the technical complexity of the process.

Telecommunications operators and companies sending commercial or customer service SMS messages
DOUE cambioslegales.es › Agriculture & Fisheries

New EU regulation on restrictions on the use of antibiotics in animals intended for food

05 Jun 2026 5/10 Agriculture & Fisheries Effective: 04/06/2026

The EU updates the rules on which antibiotics are prohibited or restricted in farm animals. It affects livestock farmers and veterinarians who use these medicines.

Livestock farmers, veterinarians, importers of animal products and health authorities
DOUE cambioslegales.es › European Regulations

New EU regulation on microplastics: exceptions for medicines and research

02 Jun 2026 5/10 European Regulations Effective: 02/06/2026

The EU modifies restrictions on synthetic polymer microparticles (microplastics) to clarify exceptions for medicines, clinical trials and research. Conditions are also specified for products with microplastics encapsulat...

Manufacturers, distributors and users of microplastic products; pharmaceutical and research sectors
BOE cambioslegales.es › Other Regulations

Congress approves changes in outpatient medication copayment

30 May 2026 5/10 Effective: 13/05/2026

Congress has ratified the decree that modifies what patients pay for their medications in pharmacies. The changes affect users and beneficiaries of the outpatient pharmaceutical benefit.

Patients, SNS beneficiaries, pharmacies and pharmaceutical benefit managers
DOUE cambioslegales.es › European Regulations

Correction of errors in European regulations on hazardous substances in cosmetics

19 May 2026 5/10 European Regulations Effective: 13/01/2026

Errors are corrected in the European regulation governing the use of carcinogenic, mutagenic or toxic substances in cosmetic products. It affects manufacturers and distributors in the cosmetic sector.

Manufacturers, distributors and importers of cosmetic products in the EU
BOE cambioslegales.es › Social Security

New economic aid for persons with extreme dependency (Grade III+) in Spain

14 May 2026 5/10 Social Security Effective: 17/03/2026

Specific economic benefits are created for persons with the highest degree of dependency. The social services law is also modified to adapt to this new regulation.

Persons with extreme dependency Grade III+, families, caregivers and social services
DOUE cambioslegales.es › Agriculture & Fisheries

New European regulation on the use of veterinary medicines to prevent animal diseases on the list

13 May 2026 5/10 Agriculture & Fisheries

The EU updates the rules on which veterinary medicines can be used to prevent and control animal diseases considered a priority. It affects livestock farmers, veterinarians and companies in the animal sector.

Livestock farmers, veterinarians, veterinary pharmaceutical industry and animal health authorities