Regulatory Updates

Distribution date: 20 October 2020 | Final date for Comment: 19 December 2020

The Ministry of Food and Drug Safety of the Republic of Korea is partly revising the “Pharmaceutical Affairs Act”. The main contents are: For the pharmaceutical imported, similar to pharmaceutical manufactured, the distribution has been managed thoroughly by prescribing the prohibition another pharmaceutical that is not identical with the approved and reported information such as ingredient and amount from importing, storing and displaying for the purpose of marketing. Under “Safety Control Act of Household Chemicals and Biocidal Product” (Established on 20 Mar 2018; Implemented on 1 Jan 2019), the managing body shall be excluded in the scope of quasi-drug as nematicide and humidifier disinfectant of fly and mosquito that were controlled as quasi-drug according to “Pharmaceutical Affairs Act” was changed. (Article 2, 62 and 68-4)

Products Covered: Pharmaceuticals, Quasi-drug

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of pesticides informing the existence of a new formula changing its composition. This regulation will be also notified to the SPS committee.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of pesticides informing the existence of a new formula changing its composition. This regulation will be also notified to the SPS committee.

Products Covered: HS Code(s): 38089910 (pesticides)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of sanitizing products informing the existence of a new formula changing its composition.

Products Covered: Mixtures of odoriferous substances and mixtures, incl. alcoholic solutions, based on one or more of these substances, of a kind used as raw materials in industry (excl. food or drink industries) (HS code(s): 330290); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 340120); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of sanitizing products informing the existence of a new formula changing its composition.

Products Covered: Mixtures of odoriferous substances and mixtures, incl. alcoholic solutions, based on one or more of these substances, of a kind used as raw materials in industry (excl. food or drink industries) (HS code(s): 330290); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 340120); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of personal hygiene products (including disposable products), cosmetics, and perfumes informing the existence of a new formula changing its composition.

Products Covered: HS 340130; 9619

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of personal hygiene products (including disposable products), cosmetics, and perfumes informing the existence of a new formula changing its composition.

Products Covered: HS 340130; 9619

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of low risk notified medicines products, herbal medicinal products, and cannabis-based medicine informing the existence of a new formula changing its composition.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS code(s): 3006); True hemp "Cannabis sativa L.", raw or processed, but not spun; tow and waste of true hemp, incl. yarn waste and garnetted stock (HS code(s): 5302); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of low risk notified medicines products, herbal medicinal products, and cannabis-based medicine informing the existence of a new formula changing its composition.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS code(s): 3006); True hemp "Cannabis sativa L.", raw or processed, but not spun; tow and waste of true hemp, incl. yarn waste and garnetted stock (HS code(s): 5302); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 19 October 2020

This Normative Instruction establishes the inclusion of a declaration in the label of medical devices informing the existence of a new formula changing its composition.

Products Covered: Dried glands and other organs for organo-therapeutic uses, whether or not powdered; extracts of glands or other organs or their secretions, for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, n.e.s. (HS code(s): 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS code(s): 3006)

Regulation Type: Regular notification