Public notification of the Ministry of Health and Welfare as long as the name of a drug, etc. already permitted cannot be used as the name of the drug, etc.

As long as the name of a drug, etc. can not be used as the name of the product such as a drug, the method of improvement and the guidelines for marketing approval of the Ministry of Health and Social Affairs of Article 91-80 of the notification of the Ministry of Health and Social Affairs are illegal as it limits the free economic activities of the people, without

Articles 26(1) and 26(7) of the Pharmaceutical Affairs Act, Article 12 of the former Enforcement Rule of the Pharmaceutical Affairs Act (amended by the Ordinance of the Ministry of Health and Welfare No. 891 of Jun. 30, 1992)

[Plaintiff-Appellant-Appellee] Plaintiff 1 and 1 other (Law Firm Domin, Attorneys Park Jae-soo and 1 other, Counsel for plaintiff-appellant-appellee-appellant-appellee-appellant-Appellee-Appellant-Appellee-Appellant-Appellee-Appellee-Appellee-Appellant-Appellee-Appellee-Appellant-Appellee-Appellee-Appellee-Appellant-Appellee-Appellee-Appellant-Appellee-Appellee-Appellant-Appellee-Appellee-Appellant-Appellee-Appellee-Appellant-Appellee-Appellee-Appellant-Appellee-Appellee-

주식회사 한국존슨앤드존슨

The Minister of Health and Welfare

Colonel Business Corporation

1. The disposition of the defendant against the plaintiff on January 27, 1992 that the defendant applied for marketing approval of cosmetics and non-pharmaceutical drugs listed in the separate sheet shall be revoked.

2. Of the costs of lawsuit, the part resulting from the participation is borne by the Intervenor joining the Defendant, and the remainder is borne by the Defendant.

The same shall apply to the order.

1. Details of the disposition;

On December 27, 1991, the plaintiff's application for item permission for manufacturing cosmetics and non-pharmaceutical drugs listed in the attached list was defective to the defendant on December 27, 1991, and on December 30, 1991, and on January 15, 1992, the defendant ordered the plaintiff to supplement the plaintiff to change the name of the product on the grounds that the defendant already obtained item permission for cosmetics and non-pharmaceutical drugs from the defendant on May 19, 1986 from the defendant on May 19, 196, and that if the same or similar name is permitted as a product name, it does not meet the requirements for product name such as confusion to ordinary consumers, etc., but the fact that the plaintiff rejected the above application of the plaintiff on January 27, 1992 is not disputed between the parties, or that the defendant rejected the application in accordance with the purport of the arguments as stated in subparagraphs 8 through 10 and each of the whole arguments.

2. Judgment on the main defense of this case

The intervenor, prior to the amendment of the Ordinance of the Ministry of Health and Welfare, Article 22 of the Enforcement Rule of the Pharmaceutical Affairs Act was amended on March 5, 1993, and enforced on July 1, 1993. According to the above amended regulations, for cosmetics and non-pharmaceutical drugs, the permission for items should be abolished and the permission for items should be obtained only. Thus, the plaintiff can manufacture and sell them using the name of "Paena" when the type of "children's shampoo and shoo" is permitted for the use of "children's shampoo" for example, as the plaintiff can sell and sell them, even though the lawsuit of this case was revised as above, it is argued that there is no benefit of lawsuit because of no practical benefit and there is no benefit of lawsuit as the plaintiff, even if the judgment standard of this case was revised as above, and it was transferred on June 10, 1993, which is the date of the closing of argument of this case. Therefore, the intervenor's assertion is without merit

3. Whether the disposition is lawful;

The defendant asserts that the disposition of this case is lawful on the basis of Article 26 (1) and (7) of the Pharmaceutical Affairs Act and Article 5 (1) 1 and 2 of the Guidelines for Manufacturing and Manufacturing Approval of Drugs, etc. No. 91-80 based on the above guidelines. The plaintiff's above application of this case satisfies all requirements of Article 26 of the Pharmaceutical Affairs Act and Article 12 of the Enforcement Rule of the Pharmaceutical Affairs Act, and the permission under the above Act constitutes an act of binding discretion. The defendant rejected the above application on the ground that the already permitted name as a medicine name under Article 5 (1) 2 of the above Guidelines cannot be used as a product's name, but the above application is illegal to restrict the free economic activities of the people without any ground under the parent law, and therefore the above rejection disposition should be revoked.

Therefore, with respect to the relevant Acts and subordinate statutes, Article 26 (1) of the Pharmaceutical Affairs Act provides that "any person who intends to engage in the manufacturing or subdivision of drugs, non-pharmaceutical drugs, cosmetics, medical appliances, or sanitary supplies (hereinafter referred to as "drugs, etc.") shall obtain manufacturing permission for each category of business, factory, etc., and shall obtain permission for items or make a report on items by item under the conditions as prescribed by the Ordinance of the Ministry of Health and Welfare, and the same shall apply to the case where he intends to modify permitted or reported matters." Article 26 (7) of the same Act provides that "the Minister of Health and Welfare may, when he deems it necessary for the public interest in granting permission under the provisions of paragraph (1), choose not to grant permission for specific areas or items. In this case, matters concerning the specific areas or items shall be announced in advance, and Article 12 of the Enforcement Rule of the same Act (amended by the Ordinance of the Ministry of Health and Welfare No. 891 of Jun. 30, 192) provides that permission for manufacturing business by category of drugs, etc.

In this context, it is necessary to examine whether Article 5 (1) 2 of the above Guidelines is valid based on laws and regulations.

Article 26(1) of the Pharmaceutical Affairs Act and Article 12 of the Enforcement Rule of the same Act, in cases where an application for permission meets the requirements of the above Act, the pertinent administrative agency must grant permission, barring special circumstances, and in the sense that such permission cannot be refused despite the need for the public interest (see, e.g., Supreme Court Decisions 87Nu24, Feb. 24, 87; 86Nu376, Dec. 10, 85; 85Nu674, Dec. 10, 85). Article 26(7) of the Pharmaceutical Affairs Act cited by the Defendant provides that only the specific area or “specific item” may be excluded from permission only in cases where public interest needs arise. Thus, it cannot be seen that Article 5(1)5 of the Pharmaceutical Affairs Act provides that if an application for permission includes items harmful to human body, the pertinent administrative agency may limit the scope of items as a whole, and thus, it can not be seen that the above guidelines are based on the same guidelines to the Defendant.

In addition, according to the above Gap evidence Nos. 8 and 10 of the above guidelines as the grounds for the above disposition of return, the defendant's grounds for the above disposition of return can be acknowledged to be only that the defendant filed an application for permission under the name of the same product as the product already permitted under Article 5 (1) No. 2 of the above guidelines. Thus, the defendant's grounds for the above disposition of return cannot be asserted for the legitimacy of the above disposition of return on a separate ground that is not based upon the defendant's own grounds.

4. Conclusion

Thus, the above disposition by the defendant is in accordance with the illegal administrative guidelines which are not based on the laws and regulations, and it shall also be revoked illegally. Therefore, the plaintiff's claim seeking the revocation of the appeal shall be justified and the litigation costs shall be borne by the losing party and it shall be decided as per Disposition (attached Form omitted)

Judges Yu Tae-tae (Presiding Judge)