Regulatory Updates
Amendments to the Enforcement Ordinance of the Standards of Feed and Feed Additives (Amendment of an agricultural chemical residue standard).
Distribution date: 01 July 2020 | Final date for Comment: 30 August 2020
Proposal for the amendments of the Extraneous Maximum Residue Limit maximum limits (EMRLs) for the pesticide: Heptachlor. Commodity (for feed) Proposed MRL(mg/kg) Current MRL(mg/kg) Compound feed for cattle, sheep, 0.02 0.02 goat or deer Compound feed for pig 0.02 0.02 Compound feed for chicken or quail 0.02 0.02 Rice straw 0.02 - Rice whole crop silage 0.02 - Unprocessed rice 0.02 - Residue definition for enforcement: Sum of heptachlor and heptachlor epoxide
Products Covered: Compound feed (HS Code: 23.09), Rice straw, Rice whole crop silage, Unprocessed rice (HS Code: 23.08)
Regulation Type: Regular notification
Those foods, food additives, food utensils, food containers or packaging classified under 4 specific CCC codes
Distribution date: 30 June 2020 | Final date for Comment: 29 August 2020
The measure notified as G/SPS/N/TPKM/522 on 24 March 2020, was promulgated on 19 June 2020, and will come into effect on 1 July 2020. Commodities classified under four specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for foods, food additives, food utensils, food containers or packaging. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.
Products Covered:
Regulation Type: Addendum to Regular Notification
Those foods, food additives, food utensils, food containers or packaging classified under 4 specific CCC codes
Distribution date: 30 June 2020 | Final date for Comment: 29 August 2020
The measure notified as G/SPS/N/TPKM/522 on 24 March 2020, was promulgated on 19 June 2020, and will come into effect on 1 July 2020. Commodities classified under four specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for foods, food additives, food utensils, food containers or packaging. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.
Products Covered:
Regulation Type: Addendum to Regular Notification
Resolution – RDC no. 392 on 26 May 2020
Distribution date: 29 June 2020
This resolution establishes temporary and extraordinary criteria for the application of exceptionalities to specific technical requirements of the Good Manufacturing and Import Practice of Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health emergency of the new coronavirus (Covid-19).
Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).
Regulation Type: Regular notification
Resolution – RDC no. 392 on 26 May 2020
Distribution date: 29 June 2020
This resolution establishes temporary and extraordinary criteria for the application of exceptionalities to specific technical requirements of the Good Manufacturing and Import Practice of Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health emergency of the new coronavirus (Covid-19).
Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).
Regulation Type: Regular notification
Draft Resolution no. 817, 01 June 2020
Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes warning phrases for substances and or therapeutic classes in leaflets and packaging of medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Draft Resolution no. 817, 01 June 2020
Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes warning phrases for substances and or therapeutic classes in leaflets and packaging of medicines.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
Decreto Ejecutivo No. 490 de 4 de octubre de 2019, que reglamenta la Ley 90 de 26 de diciembre de 2017 sobre dispositivos médicos y productos afines, conforme fue modificada por la ley 92 de 12 de septiembre de 2019 (Executive Decree No. 490 of 4 October 2019 laying down regulations for Law No. 90 of 26 December 2017 on medical devices and related products, as amended by Law No. 92 of 12 September 2019) (27 pages, in Spanish)
Distribution date: 29 June 2020
The notified Executive Decree lays down regulations for Law No. 90 of 2017, amended by Law No. 92 of 2019, which governs all aspects relating to the manufacturing, packaging, importation, exportation, re-exportation, information, advertising, labelling, distribution, marketing, storage, use and final disposal of medical devices and related products in Panama, including in vitro medical devices. In addition, it establishes the National Directorate for Medical Devices, which will be the authority responsible for regulating and monitoring medical devices and related products in Panama. It also regulates all aspects relating to operating licences; requirements for issuing, renewing, updating and correcting technical criteria certificates; the monitoring of medical devices; and fees and penalties.
Products Covered: Chapter 90, headings: 90.02; 90.03; 90.04; 90.10; 90.11; 90.12; 90.18; 90.19; 90.20; 90.21 and 90.22. Chapter 94, heading 94.02: Medical, surgical or dental furniture. Other headings: 94.02.10; 94.03.10; 25.20; 35.02; 34.07 and 30.06.
Regulation Type: Regular notification
Decreto Ejecutivo No. 490 de 4 de octubre de 2019, que reglamenta la Ley 90 de 26 de diciembre de 2017 sobre dispositivos médicos y productos afines, conforme fue modificada por la ley 92 de 12 de septiembre de 2019 (Executive Decree No. 490 of 4 October 2019 laying down regulations for Law No. 90 of 26 December 2017 on medical devices and related products, as amended by Law No. 92 of 12 September 2019) (27 pages, in Spanish)
Distribution date: 29 June 2020
The notified Executive Decree lays down regulations for Law No. 90 of 2017, amended by Law No. 92 of 2019, which governs all aspects relating to the manufacturing, packaging, importation, exportation, re-exportation, information, advertising, labelling, distribution, marketing, storage, use and final disposal of medical devices and related products in Panama, including in vitro medical devices. In addition, it establishes the National Directorate for Medical Devices, which will be the authority responsible for regulating and monitoring medical devices and related products in Panama. It also regulates all aspects relating to operating licences; requirements for issuing, renewing, updating and correcting technical criteria certificates; the monitoring of medical devices; and fees and penalties.
Products Covered: Chapter 90, headings: 90.02; 90.03; 90.04; 90.10; 90.11; 90.12; 90.18; 90.19; 90.20; 90.21 and 90.22. Chapter 94, heading 94.02: Medical, surgical or dental furniture. Other headings: 94.02.10; 94.03.10; 25.20; 35.02; 34.07 and 30.06.
Regulation Type: Regular notification
Draft Normative Instruction no. 816, 01 June 2020
Distribution date: 29 June 2020 | Final date for Comment: 07 September 2020
This draft resolution establishes technical requirements for labelling of large-volume parenteral solutions, solutions for irrigation, dialysis, plasma expanders and small-volume parenteral solutions.
Products Covered: HS Code(s): 3003; 3004; 3005; 2941 (pharmaceutical products).
Regulation Type: Regular notification
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