Distribution date: 12 August 2020 | Final date for Comment: 14 May 2025

This resolution establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2).

Products Covered: Antibiotics. (HS code(s): 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 12 August 2020 | Final date for Comment: 14 May 2025

This resolution establishes control measures for medicines that contain substances mentioned by the Annex I of this resolution, isolated or in association with other drugs, due to the international public health emergency of the new coronavirus (SARS-CoV-2).

Products Covered: Antibiotics. (HS code(s): 2941); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 14 August 2020 | Final date for Comment: 01 September 2020

New procedure announced by the Pharmaceutical Division at Israel's Ministry of Health called "Procedure for Packaging Labeling of Medical Preparations (PRA-043/03)". This procedure replaces a previous procedure from July 2007 (amended in July 2012) and is based on Regulation 20 of the "Pharmacists Regulations (Preparations) 5746-1986" and regulation 13 of the "Pharmacists Regulations (Sale of an over-the-counter preparation not in a pharmacy or not by a pharmacist) 5765-2004". The purpose of the procedure is to clarify the requirements of Regulation 20 and Regulation 13 and to ensure that all packaging requirements shall appear on the preparation packaging, listed in the Preparations Register, in order to provide patients with the essential information regarding the preparation and assist in providing safe and effective drug treatment. It collects all existing requirements into a unified list that contains also references to similar international requirements.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 14 August 2020 | Final date for Comment: 01 September 2020

New procedure announced by the Pharmaceutical Division at Israel's Ministry of Health called "Procedure for Packaging Labeling of Medical Preparations (PRA-043/03)". This procedure replaces a previous procedure from July 2007 (amended in July 2012) and is based on Regulation 20 of the "Pharmacists Regulations (Preparations) 5746-1986" and regulation 13 of the "Pharmacists Regulations (Sale of an over-the-counter preparation not in a pharmacy or not by a pharmacist) 5765-2004". The purpose of the procedure is to clarify the requirements of Regulation 20 and Regulation 13 and to ensure that all packaging requirements shall appear on the preparation packaging, listed in the Preparations Register, in order to provide patients with the essential information regarding the preparation and assist in providing safe and effective drug treatment. It collects all existing requirements into a unified list that contains also references to similar international requirements.

Products Covered: Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 19 August 2020 | Final date for Comment: 18 October 2020

The Provisions are to ensure the safety of cosmetics by regulating the registration and filing of cosmetics and new ingredients.

Products Covered: ICS: 71.100.70 HS: 33

Regulation Type: Regular notification

Distribution date: 19 August 2020 | Final date for Comment: 18 October 2020

The Provisions are to ensure the safety of cosmetics by regulating the registration and filing of cosmetics and new ingredients.

Products Covered: ICS: 71.100.70 HS: 33

Regulation Type: Regular notification

Distribution date: 19 August 2020 | Final date for Comment: 18 October 2020

The Provisions for the Supervision and Administration of Cosmetics Production and Distribution includes 8 parts including general guidelines, management of production license, quality management of production, quality management of distribution, management of on-line sales, supervision and administration, legal liability and attachment. It totally consists of 100 articles.

Products Covered: Cosmetics ICS: 71.100.70, HS: 33

Regulation Type: Regular notification

Distribution date: 19 August 2020 | Final date for Comment: 18 October 2020

The Provisions for the Supervision and Administration of Cosmetics Production and Distribution includes 8 parts including general guidelines, management of production license, quality management of production, quality management of distribution, management of on-line sales, supervision and administration, legal liability and attachment. It totally consists of 100 articles.

Products Covered: Cosmetics ICS: 71.100.70, HS: 33

Regulation Type: Regular notification

Distribution date: 20 August 2020 | Final date for Comment: 19 September 2020

In order to promote utilization of compost and fertilizers made of industrial by-products, the MAFF will amend the Ordinance for the Enforcement of the Fertilizer Regulation Act and the administrative rules as follows: 1. Designation of the “designated mixed fertilizers”, as an additional category, which may be produced in and imported to Japan only requiring notification to the MAFF or to one of the Japanese prefectural governments. (1) Fertilizers which fall into the following categories I to III are considered as “designated mixed fertilizers” as far as their mixing processes (including granulation: same as in hereafter) do not have possibility to deteriorate the quality (e.g. chemical changes). I   mixed fertilizers produced only from registered normal fertilizers1 II mixed fertilizers produced from registered normal fertilizers and registered special fertilizers2 III mixed fertilizers produced from registered normal fertilizers and/or special fertilizers and soil amendments Followings are examples of fertilizers which are not considered as the “designated mixed fertilizers”. mixed fertilizers produced from compost (or sewage sludge) which contains 50% or more water fertilizers produced from the  (A) and (B) bellow (unless their mixing processes deteriorate the quality) (A) alkaline fertilizers (B) non-alkaline fertilizers or sulfur 1,2  The “normal fertilizers” and “special fertilizers” are defined in the Fertilizer Regulation Act. The Act is available from the following link: http://www.japaneselawtranslation.go.jp/law/detail/?ft=1&re=2&dn=1&x=57&y=16&co=01&ia=03&ja=04&ky=fertilizer&page=18 (2) The soil amendments listed below may be used for producing the “designated mixed fertilizers” specified in III of 1.(1): peat, humic acid, woody peat, granulated calcined diatomaceous earth, zeolite, vermiculite, perlite, bentonite and vesicular-arbuscular mycorrhiza (3) Mixed “special fertilizers” are defined as below: “Mixed fertilizers produced exclusively from special fertilizers” is additionally designated as special fertilizers. The mixed special fertilizers may be produced in and imported to Japan under the same notification procedure as “special fertilizer”. Similar labelling requirements to those for compost is stipulated for the mixed special fertilizers. The labelling requirements include the name of main raw materials, amount of ingredient, production date, the name of producers among others. (4) The assurance label for “designated mixed fertilizer” is required to indicate the following information: description which proves that the label is  “producer assurance label” or “importer assurance label”; name of the fertilizers guaranteed component amount (or the amount of the major components for the fertilizer corresponding to 1.(1) II and III) name and address of the producer or importer; year and month of production or import; (in the case of producer) name and location of the workplace for the production; net weight; (in the case of designated mixed fertilizer) discription that the fertilizer is a designated mixed fertilizer; (in the case of designated mixed fertilizer which contains special fertilizer(s))  type/name and proportion of normal fertilizer(s) and/or special fertilizer(s) (in the case of designated mixed fertilizer which contains soil amendment(s))  type/name and proportion of normal fertilizer(s), special fertilizer(s) and soil amendment(s) type/name of the raw materials 2. Relaxation of the requirements for the assurance labelling (1) Minimum amount of the major components which is required to be indicated on the assurance label is lowered. The required minimum amount for alkalinity (AL) and Acid-silicon (SiO2) is lowered to 5% or more of the product weight (currently 10% or more). (2) Regarding the assurance labels, the current requirement of size (bigger than 10.8cm long and 7.2cm wide) is abandoned while the font size requirement is introduced so that it should not be smaller than 8 point (Japanese Industrial Standards Z8305). 3. Amendment of the labelling requirements for mixed organic fertilizers Mixed organic fertilizers are, similarly to other mixed fertilizers, required to indicate all the raw materials that contain nitrogen on their labels. Although in the current regulation, it is required to indicate all the raw materials in descending order according to the percentage weight in the product, the following description will be also allowed after the amendment: I Five or more raw materials, or raw materials consisting eighty percent or more of the fertilizers should be listed first in descending order of weight ratio, followed by “others” in which the remaining raw materials shall be listed with parenthesis (“no particular order” required in the parenthesis). II If the actual order of the two adjacent raw materials may be changed depending on the lots, the possibility of the change may be described. However, the “others” should always stay at the end of the list.

Products Covered: Fertilizer (HS: 3101, 3102, 3103, 3104, 3105)

Regulation Type: Regular notification

Distribution date: 20 August 2020 | Final date for Comment: 19 September 2020

In order to promote utilization of compost and fertilizers made of industrial by-products, the MAFF will amend the Ordinance for the Enforcement of the Fertilizer Regulation Act and the administrative rules as follows: 1. Designation of the “designated mixed fertilizers”, as an additional category, which may be produced in and imported to Japan only requiring notification to the MAFF or to one of the Japanese prefectural governments. (1) Fertilizers which fall into the following categories I to III are considered as “designated mixed fertilizers” as far as their mixing processes (including granulation: same as in hereafter) do not have possibility to deteriorate the quality (e.g. chemical changes). I   mixed fertilizers produced only from registered normal fertilizers1 II mixed fertilizers produced from registered normal fertilizers and registered special fertilizers2 III mixed fertilizers produced from registered normal fertilizers and/or special fertilizers and soil amendments Followings are examples of fertilizers which are not considered as the “designated mixed fertilizers”. mixed fertilizers produced from compost (or sewage sludge) which contains 50% or more water fertilizers produced from the  (A) and (B) bellow (unless their mixing processes deteriorate the quality) (A) alkaline fertilizers (B) non-alkaline fertilizers or sulfur 1,2  The “normal fertilizers” and “special fertilizers” are defined in the Fertilizer Regulation Act. The Act is available from the following link: http://www.japaneselawtranslation.go.jp/law/detail/?ft=1&re=2&dn=1&x=57&y=16&co=01&ia=03&ja=04&ky=fertilizer&page=18 (2) The soil amendments listed below may be used for producing the “designated mixed fertilizers” specified in III of 1.(1): peat, humic acid, woody peat, granulated calcined diatomaceous earth, zeolite, vermiculite, perlite, bentonite and vesicular-arbuscular mycorrhiza (3) Mixed “special fertilizers” are defined as below: “Mixed fertilizers produced exclusively from special fertilizers” is additionally designated as special fertilizers. The mixed special fertilizers may be produced in and imported to Japan under the same notification procedure as “special fertilizer”. Similar labelling requirements to those for compost is stipulated for the mixed special fertilizers. The labelling requirements include the name of main raw materials, amount of ingredient, production date, the name of producers among others. (4) The assurance label for “designated mixed fertilizer” is required to indicate the following information: description which proves that the label is  “producer assurance label” or “importer assurance label”; name of the fertilizers guaranteed component amount (or the amount of the major components for the fertilizer corresponding to 1.(1) II and III) name and address of the producer or importer; year and month of production or import; (in the case of producer) name and location of the workplace for the production; net weight; (in the case of designated mixed fertilizer) discription that the fertilizer is a designated mixed fertilizer; (in the case of designated mixed fertilizer which contains special fertilizer(s))  type/name and proportion of normal fertilizer(s) and/or special fertilizer(s) (in the case of designated mixed fertilizer which contains soil amendment(s))  type/name and proportion of normal fertilizer(s), special fertilizer(s) and soil amendment(s) type/name of the raw materials 2. Relaxation of the requirements for the assurance labelling (1) Minimum amount of the major components which is required to be indicated on the assurance label is lowered. The required minimum amount for alkalinity (AL) and Acid-silicon (SiO2) is lowered to 5% or more of the product weight (currently 10% or more). (2) Regarding the assurance labels, the current requirement of size (bigger than 10.8cm long and 7.2cm wide) is abandoned while the font size requirement is introduced so that it should not be smaller than 8 point (Japanese Industrial Standards Z8305). 3. Amendment of the labelling requirements for mixed organic fertilizers Mixed organic fertilizers are, similarly to other mixed fertilizers, required to indicate all the raw materials that contain nitrogen on their labels. Although in the current regulation, it is required to indicate all the raw materials in descending order according to the percentage weight in the product, the following description will be also allowed after the amendment: I Five or more raw materials, or raw materials consisting eighty percent or more of the fertilizers should be listed first in descending order of weight ratio, followed by “others” in which the remaining raw materials shall be listed with parenthesis (“no particular order” required in the parenthesis). II If the actual order of the two adjacent raw materials may be changed depending on the lots, the possibility of the change may be described. However, the “others” should always stay at the end of the list.

Products Covered: Fertilizer (HS: 3101, 3102, 3103, 3104, 3105)

Regulation Type: Regular notification