Correction of errors in European regulations on authorization of human and veterinary medicines
05 Aug 202618 views
Who is affected:
Pharmaceutical industry, veterinary laboratories and medicines regulatory authorities
Summary
Technical errors in the European regulation governing the authorization and control of medicines and the functioning of the European Medicines Agency are corrected.
Detailed analysis
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This error correction affects Regulation (EU) 2019/5, which amended the European regulatory framework for authorization of human and veterinary medicines. The correction adjusts technical or editorial aspects of the text published in January 2019, without altering the regulatory substance. The original regulation estab…
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OJ:L_202690662: Corrección de errores del Reglamento (UE) 2019/5 del Parlamento Europeo y del Consejo, de 11 de diciembre de 2018, que modifica el Reglamento (CE) n.° 726/2004 por el que se establecen procedimientos comunitarios para la autorización y el control de los medicamentos de uso humano y veterinario y por el que se crea la Agencia Europea de Medicamentos, el Reglamento (CE) n.° 1901/2006 sobre medicamentos para uso pediátrico y la Directiva 2001/83/CE por la que se establece un código comunitario sobre medicamentos para uso humano (DO L 4 de 7.1.2019)
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