Notice of Consultation on the Prescription Drug List (PDL): Epinephrine (2 pages, in English and French)
Distribution date: 29 August 2019 | Final date for Comment: 26 October 2019
This Notice of Consultation provides an opportunity to comment on the proposal to add epinephrine or its salts topical solution for hemostasis when sold at a concentration equal to or greater than 1 mg/ ml (1:1000) to the Prescription Drug List (PDL). Only the Human part of the PDL is proposed to be revised.
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Proyecto de Reglamento para el Registro Sanitario de Productos Sanitarios: Artículos para Bebés (Draft regulation on sanitary registration of sanitary products: Articles for babies). (10 pages, in Spanish)
Distribution date: 29 August 2019 | Final date for Comment: 27 October 2019
The purpose of the notified regulation is to set forth the regulatory provisions for Law No. 29459, Law on pharmaceutical products, medical devices and sanitary products: Articles for babies.
Products Covered: Articles for babies; Pharmaceutical goods specified in Note 4 to this Chapter (HS 3006)
Regulation Type: Regular notification
Resolution SENASA-DMV-002-2019. Guide to good practices for the storage, transportation and distribution of products for veterinary use
Distribution date: 29 August 2019
Costa Rica hereby notifies the entry into force of the sanitary measures established in Resolution SENASA-DMV-002-2019. Text available at: https://members.wto.org/crnattachments/2019/SPS/CRI/19_4720_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the use of ionising radiation in the manufacture of medicinal products The draft normative instruction regarding Complementary guidelines to the use of ionising radiation in the manufacture of medicinal products of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 44, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of herbal medicinal products The draft normative instruction regarding Complementary guidelines to the manufacture of herbal medicinal products of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 39, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the reference and retention samples The draft normative instruction regarding Complementary guidelines to the reference and retention samples of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 48, 21 August 2019The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the qualification and validation The draft normative instruction regarding Complementary guidelines to the qualification and validation of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 47, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation The draft normative instruction regarding Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 42, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the sampling of starting and packaging materials The draft normative instruction regarding Complementary guidelines to the sampling of starting and packaging materials of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 40, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Complementary guidelines to the manufacture of investigational medicinal products The draft normative instruction regarding Complementary guidelines to the manufacture of investigational medicinal products of the draft resolution number 653, 24 May 2019 – previously notified through G/TBT/N/BRA/870 - was adopted as a final text, published as Normative Instruction number 45, 21 August 2019. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 28 August 2019
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
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