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Regulatory Law and Labelling

At H&A ABOGADOS, we help you forget about bureaucracy.

Our team is specialized in the management and processing of the administrative permits that allow you to obtain the local authorizations to commercialize your products. We pave the way.

Launching a product in a new market undoubtedly involves a lot of work.

H&A ABOGADOS makes sure that you can focus your attention on your great challenge and not worry about obtaining the necessary local approvals to market it: safety, certifications, health, labeling, etc. These requirements, which differ in each country, can frequently lead to legally relevant sanctions if not met.

Contact H&A ABOGADOS at regulatory@herrero.es

Our Regulatory Law Department offers the following:
  • Obtaining authorisations to market a product may be a long and arduous task.
  • Meeting local product labelling specifications is sometimes an enormous task that delays product marketing.
  • Additionally, however, having a registered trademark or a patent that protects our goods is not the only important thing. This protection must also be combined with the protection obtained through marketing authorisations or administrative authorisations, as well as the labelling requirements, that are established in each country.
  • Our team is accustomed to handling administrative proceedings in a wide range of countries where we provide services of this type, and we are also experts in the development of Criminal Compliance plans.

Regulatory

  • We have unified the trademark and patent portfolio with regulatory and health approval portfolios.
  • We handle administrative procedures for medicinal products (for human or veterinary use), medical devices, cosmetics, personal care products, foods and beverages.
  • We conduct and unify administrative proceedings in several countries in Europe and Latin America.
  • We simplify administrative and formal notices for approvals.

Request for and modifications of:

  • Authorisations for production, packaging, labelling, etc.
  • Marketing, distribution or transport and storage authorisations.
  • Importing/exporting authorisations.

Analysis and proceedings for:

  • Approval of mandatory labels for issuance of an approval.
  • CE approval or equivalent for labels.
  • Analysis of non-mandatory labels to comply with labelling standards.
  • These services are provided in Spain, in the European Union and in Latin America.
  • Personalised drafting of the Criminal Compliance Plan to demonstrate the company’s level of commitment to lawfulness and to avoid criminal liability under article 31 bis of the Criminal Code.
  • Identification of the activities where serious crimes that must be prevented may be committed.
  • Criminal training and prevention courses for employees.
  • Establishment of regulatory compliance protocols.
  • Audit of criminal risks and compliance models.
  • Design, implementation and management of regulatory monitoring and compliance programmes for companies based on ISO 19600.