1.

Notifying Member: COSTA RICA

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

Ministerio de Salud (Ministry of Health)

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Centro Información de Obstáculos Técnicos al Comercio (TBT Enquiry Point)

Ministerio de Economía, Industria y Comercio, MEIC (Ministry of the Economy, Industry and Trade)

Tel.: (+506) 2549-1479

Email: crotc@meic.go.cr; msolera@meic.go.cr

Website: http://www.reglatec.go.cr

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): ICS 121190

5.

Title, number of pages and language(s) of the notified document: Reglamento Técnico RTCR 515:2024. Cannabis. Productos medicinales a base de cannabis. Disposiciones administrativas, registro sanitario, etiquetado, especificaciones, control y publicidad (Costa Rican Technical Regulation (RTCR) 515:2024. Cannabis. Cannabis-based medicinal products. Administrative provisions, sanitary registration, labelling, specifications, control and advertising) (73 pages, in Spanish)

6.

Description of content: The purpose of the notified regulation is to establish the administrative provisions and requirements that are to govern and control cannabis-based medicinal products. It applies to the processed products referred to therein as medicinal products made using cannabis and raw materials containing cannabis plant derivatives, that are to be used and applied in human medicine.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

Relevant documents:

1. Executive Decree No. 44585-MP-MAG-MS of 12 July 2024, "Reglamento a la Ley N°10113, Ley del Cannabis para uso medicinal y terapéutico y del Cáñamo para uso alimentario e industrial del 02 de marzo del 2022, Reglamento del Cáñamo para Uso Alimentario e Industrial o Uso Medicinal o Terapéutico", published in Supplement No. 140 to Official Journal, La Gaceta, No. 149 of 14 August 2024.

2. Executive Decree No. 44695-MP-MAG-S of 29 August 2024, "Reglamento a la Ley N°10113, Ley del Cannabis para uso medicinal y terapéutico y del Cáñamo para uso alimentario e industrial del 02 de marzo del 2022, Reglamento del Cannabis para Uso Medicinal y Terapéutico", published in Supplement No. 173 to Official Journal, La Gaceta, No. 195 of 18 November 2024.

3. Executive Decree No. 31969-S of 26 May 2004, "Manual de Normas para la Habilitación de Farmacias", published in Official Journal, La Gaceta, No. 175 of 7 September 2004.

4. Executive Decree No. 37111-S of 12 January 2012, "Reglamento para el Control de Drogas, Estupefacientes y Psicotrópicos", published in Supplement No. 72 to Official Journal, La Gaceta, No. 108 of 5 June 2012.

5. Executive Decree No. 43259-COMEX-S-MEIC of 27 September 2021,"Publica resolución N° 446-2021 (COMIECO-XCIV) del 28/04/2021 Anexo I: Reglamento Técnico Centroamericano RTCA 11.03.59:18 Productos Farmacéuticos. Medicamentos para Uso Humano. Requisitos de Registro Sanitario", published in Supplement No. 245 to Official Journal, La Gaceta, No. 232 of 2 December 2021.

6. Executive Decree No. 36638-COMEX-S-MEIC of 30 March 2011, "Publica resolución Nº 2562010 (COMIECO-LIX) Reglamento Técnico Centroamericano RTCA 11.01.04:10 Productos Farmacéuticos. Estudios de Estabilidad de Medicamentos para Uso Humano", published in Official Journal, La Gaceta, No. 129 of 5 July 2011.

7. Executive Decree No. 43432-S of 9 March 2022, "Reglamento general para permisos sanitarios de funcionamiento, permisos de habilitación y autorización para eventos temporales de concentración masiva de personas, otorgados por el Ministerio de Salud", published in Supplement No. 60 to Official Journal, La Gaceta, No. 56 of 23 March 2022.

8. Publication of Resolution No. 472-2023 (COMIECO-EX) of 5 June 2023: Approves "Reglamento Técnico Centroamericano RTCA 11.03.64:19 Productos Farmacéuticos. Productos Naturales Medicinales Para Uso Humano. Requisitos de Registro Sanitario" and "Reconocimiento Mutuo de Registro Sanitario de Productos Naturales Medicinales para uso Humano"; and repeals Resolution No. 303-2013 (COMIECO-EX) of 15 May 2013 enacted through Executive Decree No. 37851-COMEX-MEIC-S of 27 May 2013. Publication of Resolution No. 472-2023 (COMIECO-EX) of 5 June 2023: Approves "Reglamento Técnico Centroamericano RTCA 11.03.64:19 Productos Farmacéuticos. Productos Naturales Medicinales Para Uso Humano. Requisitos de Registro Sanitario" and "Reconocimiento Mutuo de Registro Sanitario de Productos Naturales Medicinales para uso Humano"; and repeals Resolution No. 303-2013 (COMIECO-EX) of 15 May 2013 enacted through Executive Decree No. 37851-COMEX-MEIC-S of 27 May 2013.

9. Executive Decree No. 42918-COMEX-MEIC-S of 18 January 2021 publishing Resolution No. 423-2020 (COMIECO-XC) of 30 April 2020 and the annexes thereto: "Reglamento Técnico Centroamericano RTCA 11.03.69:13 Productos Farmacéuticos. Productos Naturales Medicinales para Uso Humano. Buenas Prácticas de Manufactura y su guía de verificación", published in Supplement No. 75 to Official Journal, La Gaceta, No. 73 of 16 April 2021.

10. Executive Decree No. 37988-S of 3 October 2013, "Reglamento para el Funcionamiento y la Utilización del Portal 'Regístrelo'", published in Official Journal, La Gaceta, No. 203 of 22 October 2013.

11. Executive Decree No. 39984-S of 1 September 2016, "Reglamento de Utilización y Funcionamiento del Sistema Automatizado de Receta Digital de Psicotrópicos y Estupefacientes", published in Supplement No. 252 to Official Journal, La Gaceta, No. 215 of 9 November 2016.

12. Executive Decree No. 36868-S of 12 September 2011, "Reglamento para la autorización y control sanitario de la publicidad de productos de interés sanitario", published in Official Journal, La Gaceta, No. 236 of 8 December 2011.

9.

Proposed date of adoption: Upon publication in the Official Journal

Proposed date of entry into force: Three months after publication in Official Journal La Gaceta

10.

Final date for comments: 60 days from notification

11.

Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Ministerio de Economía, Industria y Comercio, MEIC (Ministry of the Economy, Industry and Trade)

Dirección de Calidad (Quality Directorate)

Centro de Información de Obstáculos Técnicos al Comercio, CIOT (TBT Enquiry Point)

San José

Apartado P

Tel.: (+506) 22 2549 1479

Email: msolera@meic.go.cr; crotc@meic.go.cr

Website: http://www.meic.go.cr