Distribution date: 20 July 2023 | Final date for Comment: 29 April 2025

The Regulation for the conditional sanitary registration of medicines and biological products has been approved pursuant to Supreme Decree No. 020-2023-SA and will enter into force six months after publication in the Official Journal, El Peruano. Moreover, Supreme Decree No. 002-2021-SA and the amendment thereto approved by Supreme Decree No. 019-2021-SA have been repealed. Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism) Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru Tel.: (+51-1) 513-6100, Ext. 1223 and 1239 Email: [email protected][ mailto:[email protected] ] (1) This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.

Products Covered: PRODUCTOS FARMACÉUTICOS (HS code(s): 30); Productos farmacéuticos (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 24 July 2023 | Final date for Comment: 22 September 2023

The notified text concerns the registration and control of veterinary product companies and their technical officers. It addresses the modification, suspension, cancellation and renewal of their registration; companies' obligations; and the registration and control of veterinary products. The text also lays down the basic principles and requirements for the quality management systems of veterinary product companies (good manufacturing practices, good laboratory practices, good storage practices and biosecurity and bioprotection requirements).

Products Covered: Veterinary products (Chapter 30 of the Harmonized System)

Regulation Type: Regular notification

Distribution date: 24 July 2023 | Final date for Comment: 22 September 2023

The notified text concerns the registration and control of veterinary product companies and their technical officers. It addresses the modification, suspension, cancellation and renewal of their registration; companies' obligations; and the registration and control of veterinary products. The text also lays down the basic principles and requirements for the quality management systems of veterinary product companies (good manufacturing practices, good laboratory practices, good storage practices and biosecurity and bioprotection requirements).

Products Covered: Veterinary products (Chapter 30 of the Harmonized System)

Regulation Type: Regular notification

Distribution date: 24 July 2023 | Final date for Comment: 22 September 2023

The notified text concerns the registration and control of veterinary product companies and their technical officers. It addresses the modification, suspension, cancellation and renewal of their registration; companies' obligations; and the registration and control of veterinary products. The text also lays down the basic principles and requirements for the quality management systems of veterinary product companies (good manufacturing practices, good laboratory practices, good storage practices and biosecurity and bioprotection requirements).

Products Covered: Veterinary products (Chapter 30 of the Harmonized System)

Regulation Type: Regular notification

Distribution date: 25 July 2023 | Final date for Comment: 29 April 2025

This letter introduces a temporary restriction on import of live poultry and poultry products from Poland to the territory of the Russian Federation and on transit of live poultry through the Russian territory due to the outbreak of Newcastle disease in Poland.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS codes: 0105; 0407, 0408; 0207; 0208, 0209, 0210, 0410 00 000 0, 0504 00 000 0, 0505, 0511, 1501, 1506 00 000 0, 1516 10, 1518 00, 1601 00, 1602, 1603 00, 1902 20, 1904 20, products from group 20, from 2104, from 2106, 4206 00 000 0, 0106; 508 10 000 0, 0106, 9705 00 000 0; 9508 10 000 0, 0106; 2102, 2309, 2936, 3504, 3507, 3808, 3824; 3923, 3926, 4415 4416 00 000 0, 4421, 7020 00, 7309 00, 7310, 7326, 7616, 8436 10 000 0, 8436 21 000 0, 8436 29 000 0, 8436 80 900 0, 8606 91 800 0, 8609 00, 8716 39 800)

Regulation Type: Emergency notifications (SPS)

Distribution date: 25 July 2023 | Final date for Comment: 23 September 2023

The notified text concerns the registration and control of veterinary product companies and their technical officers. It addresses the modification, suspension, cancellation and renewal of their registration; companies' obligations; and the registration and control of veterinary products. The text also lays down the basic principles and requirements for the quality management systems of veterinary product companies (good manufacturing practices, good laboratory practices, good storage practices and biosecurity and bioprotection requirements).

Products Covered: Veterinary products (HS code: 30)

Regulation Type: Regular notification

Distribution date: 26 July 2023 | Final date for Comment: 24 September 2023

In view of International Organization of Legal Metrology (OIML) recommendation R126:2021 "Evidential Breath Analyzers", the technical and metrological requirements to be met by the measurement instruments known as evidential breath analysers have been standardized, with a view to ensuring the quality of the measurements that they provide. The international standard was updated in 2021 and constitutes the technical basis for the notified technical metrological regulation. The validity of the technical metrological regulation applicable to evidential breath analysers, issued under Resolution No. 88919 of 28 December 2017 and amended by Resolutions No. 32074 of 26 June 2020 and No. 38984 of 21 June 2022, has been extended until 31 December 2023.

Products Covered: 9027.10.90.00: Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes. Gas or smoke analysis apparatus. Other. 9027.89.90.00: Instruments and apparatus for physical or chemical analysis (for example, polarimeters, refractometers, spectrometers, gas or smoke analysis apparatus); instruments and apparatus for measuring or checking viscosity, porosity, expansion, surface tension or the like; instruments and apparatus for measuring or checking quantities of heat, sound or light (including exposure meters); microtomes.

Regulation Type: Regular notification

Distribution date: 26 July 2023 | Final date for Comment: 25 August 2023

The Minimum Requirements for Biological Products will be amended as follows: The standard for “Recombinant Respiratory Syncytial virus Vaccine” that is to be newly approved will be added. In addition, in regard to the standard for “pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)”, the section of “Test for immunoglobulin G content” and “Test for freedom from aggregated immunoglobulin G” will be partially amended and the section of “Test for pH, Storage and expiry date” will be deleted. The Public Notice on National Release Testing will be amended as follows: The criterion, fee and quantity for “Recombinant Respiratory Syncytial virus Vaccine” that is to be newly approved will be added. In addition, the criterion and quantity for “pH4-Treated Normal Human Immunoglobulin (Subcutaneous injection)” will be partially amended.

Products Covered:  Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

Distribution date: 27 July 2023 | Final date for Comment: 25 September 2023

The Draft Law was prepared in order to fill the gaps in the existing regulation when in the presence of the ban introduced from 07/01/2022 (on placing on the Lithuanian market electronic cigarettes and electronic cigarette refills with a liquid adapted for filling electronic cigarettes, if this liquid contains flavoring substances, except for the smell and (or) taste of tobacco), electronic cigarettes, electronic cigarette refills with a certain smell and (or) taste, other than tobacco, are still supplied to the Lithuanian market. The suggested amendments of the Law will allow smoother application of the provisions of the Law and smoother examination of cases for violation of the provisions of this Law, in order to reduce attractiveness and consumption of e-cigarettes and electronic cigarette refills (especially to young people). Considering the fact that it is not appropriate to indicate that the product contains nicotine on a product that does not contain nicotine, and in order to avoid misleading of users of electronic cigarettes and their refills, in draft Law it is suggested not to apply the requirement established in the Law for a warning about possible harm to health to electronic cigarettes and electronic cigarette refills that do not contain nicotine.

Products Covered: TOBACCO AND MANUFACTURED TOBACCO SUBSTITUTES; PRODUCTS, WHETHER OR NOT CONTAINING NICOTINE, INTENDED FOR INHALATION WITHOUT COMBUSTION; OTHER NICOTINE CONTAINING PRODUCTS INTENDED FOR THE INTAKE OF NICOTINE INTO THE HUMAN BODY (HS code(s): 24); Tobacco, tobacco products and related equipment (ICS code(s): 65.160)

Regulation Type: Regular notification

Distribution date: 27 July 2023 | Final date for Comment: 05 September 2023

'Pharmaceutical Affairs Act' was revised (Act No. 19359, promulgated on Apr 18, 2023, enforced on Oct 19, 2023) with the matter concerning establishing periodic monitoring system for illegal sale, advertisement of pharmaceuticals online and requesting the provider to take a measure on the violation. The revision aims to compensate the inadequacies of the current operating system including preparing the entrust ground for reporting production·export·import performance of pharmaceutical, etc. while determining matters entrusted by law and matters necessary for their implementation including prescribing measures to notify consumers of illegal sales advertisement and designating monitoring agency and organization.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification