ZL101_00_007e_WL Guidance document Authorisation of human medicinal product with known active pharmaceutical substance From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on authorizing human medicinal products with known active pharmaceutical substances. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
ZL101_00_005e_WL Guidance document Authorisation of human medicinal product with new active substance From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on authorizing human medicinal products with new active substances. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
ZL000_00_029e_WL Guidance document Packaging texts for veterinary medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on packaging texts for veterinary medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) πͺπΊ Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
ZL000_00_021e_WL Guidance document Packaging for human medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on packaging for human medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ZL000_00_027e_WL Guidance document Product information for human medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document providing product information for human medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on July 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) β¦/... laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices From European Parliament πͺπΊ A draft implementing regulation detailing procedural rules for cooperation among Member State Coordination Group, Commission, and European Medicines Agency on joint clinical assessments and scientific consultations for medicinal products and medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 26, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices) From European Parliament πͺπΊ A proposal for a decision within the European Union regarding an amendment to technical regulations and protocols in the EEA Agreement for enhanced crisis management in medicinal products and medical devices. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 11, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
ZL000_00_017e_WL Guidance document Authorisation of veterinary medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on authorisation of veterinary medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on June 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ZL112_00_002e_WL Guidance document Notification procedure for veterinary medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on notification procedure for veterinary medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on June 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ZL000_00_019e_WL Guidance document Authorisation human medicinal product under Art. 13 TPA From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document for authorizing human medicinal products under Article 13 of the Therapeutic Products Act (TPA). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Innovation and Orientation Desk From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Procedure Innovation and Orientation Desk Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Borderline products: how to tell if your product is a medicine From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ How the MHRA makes decisions on what is a medicinal product (borderline products). Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on January 8, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ZL101_00_009e_WL Guidance document Authorisation of Asian medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on authorizing Asian medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on January 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Commission Implementing Decision (EU) 2023/2634 of 27Β November 2023 concerning the extension of the action taken by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Regulation (EU) NoΒ 528/2012 of the European Parliament and of the Council (notified under document C(2023) 7951) From European Parliament πͺπΊ Commission extends permission for the use of biocidal product Biobor JF in accordance with EU regulations. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 27, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
ZL101_00_016e_WL Guidance document Authorisation of Homeopathics, anthroposophics and other complementary medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on authorizing homeopathics, anthroposophics, and other complementary medicinal products. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 15, 2023 Other (Non-Commercial) 0 reuses 0 favorites
ZL000_00_028e_WL Guidance document Product information for veterinary medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document providing product information for veterinary medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
ZL000_00_018e_WL Guidance document Authorisation veterinary medicinal product under Art. 13 TPA From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document for authorizing veterinary medicinal products under Article 13 of the TPA. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 22, 2023 Other (Non-Commercial) 0 reuses 0 favorites
ZL109_00_002e_WL Guidance document Temporary authorisation of veterinary medicinal products From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on temporary authorization of veterinary medicinal products. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
ZL108_00_002e_WL Guidance document Authorisation of co-marketing medicinal product From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Guidance document on authorisation of co-marketing medicinal product . Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites