Regulatory Updates

Distribution date: 26 August 2019 | Final date for Comment: 25 October 2019

A maximum limit for perchlorate in water (drinking water) is established. It is set at 4 µg/l. Reason for this is health protection of consumers.

Products Covered: Drinking water

Regulation Type: Regular notification

Distribution date: 26 August 2019

Products Covered: Biological products

Regulation Type: Corrigendum to Regular Notification

Distribution date: 26 August 2019 | Final date for Comment: 25 October 2019

This standard specifies the  terms and definitions, requirements, testing methods and inspection rules for toxic and harmful elements in fertilizers.

Products Covered: Fertilizers

Regulation Type: Regular notification

Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019

This draft resolution establishes criteria for certification of Good Manufacturing Practice for international companies that manufacture Active Pharmaceutical Ingredients (API).

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019

This draft resolution proposes the establishment of the Dossier for Active Pharmaceutical Ingredient (API) and of the Adequacy Charter of the Dossier for Active Pharmaceutical Ingredient.

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019

This draft resolution proposes the changing of the Resolution – RDC number 200, December 26th, 2017, and of the RDC number 73, April 7th, 2016, for the submission of the Dossier for Active Pharmaceutical Ingredient (API) in the market authorization and post-market authorization of medicines, respectively.

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

Distribution date: 21 August 2019 | Final date for Comment: 21 October 2019

This draft resolution establishes guidelines for authorization of suppliers related to the Technical Regulation for Good Practice of Distribution and Fractioning of Active Pharmaceutical Ingredients (API).

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

Distribution date: 15 August 2019 | Final date for Comment: 26 September 2019

The notified regulation opens a 45-day period for public consultation on the draft of a technical regulation for production, control and use of autogenous vaccines.

Products Covered: HS 3002.30 - Veterinary vaccines

Regulation Type: Regular notification

Distribution date: 15 August 2019 | Final date for Comment: 26 August 2019

The notified regulation opens a 45-day period for public consultation on the draft of a technical regulation that aims to define the formulation requirements, production, quality control and labelling of products for hygiene and beauty care for animals and make their registration mandatory with automatic granting by the Ministry of Agriculture, Livestock and Supply.

Products Covered: HS 3002.90.90 – Other animal products

Regulation Type: Regular notification

Distribution date: 15 August 2019

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from Republic of Serbia.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen with the exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the feeds production (for non-productive animals and fur) animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)