Whether the Public Notice No. 79 of the Ministry of Health and Welfare of December 16, 1964 is invalid.

No. 79 of Dec. 16, 1964, the Ministry of Health and Social Affairs published by subdividing and embodying the contents of the Pharmaceutical Affairs Act and the Enforcement Rule of the Pharmaceutical Affairs Act. Among them, the authority to prepare clinical laboratory data prescribed by the Enforcement Rule of the Pharmaceutical Affairs Act is limited to general hospitals, and the test, for instance, the manufacturer of medicines such as those that provide not less than 60 items for the purpose of enhancing the requirements according to the application for permission to manufacture medicines. However, the invalidation of imposing obligations in violation of the Pharmaceutical Affairs Act or the Enforcement Rule of the Pharmaceutical Affairs Act cannot be said to be the public notice, and it is reasonable to view that it is a justifiable public notice to clarify the efficacy and effects of drugs that

Article 69 of the Constitution, Article 26 of the Pharmaceutical Affairs Act

Plaintiff, Ltd.

The Minister of Health and Welfare

The plaintiff's claim is dismissed.

Litigation costs shall be borne by the plaintiff.

The defendant's disposition of non-permission on October 25, 1967 shall be revoked.

The judgment to the effect that the lawsuit costs are borne by the defendant.

On October 7, 1967, the Plaintiff filed an application for permission for the manufacturing industry of pharmaceutical products and for manufacturing products with respect to Maternia, which is a treatment agent for Maternal Diseases, and the fact that the Defendant did not grant permission on October 25, 1967 is no dispute between the parties.

In the filing of the instant application, the Defendant’s litigation performer did not attach more than two general hospitals with respect to new drugs, the requirements under the Pharmaceutical Affairs Act and the Enforcement Rule of the Pharmaceutical Affairs Act, to the determination and validity of efficacy, which have undergone 60 or more clinical trials by a professional doctor, and the basic experimental data on their toxicity and toxicity. Moreover, the Plaintiff’s non-permission disposition was lawful inasmuch as the Plaintiff’s prescription and the prescription submitted at the time of the instant application were different from each other, and thus, the Plaintiff’s assertion that the non-permission disposition was legitimate.

Therefore, according to the provisions of Article 26 of the Pharmaceutical Affairs Act, Article 12 and Article 57 of the Enforcement Rule of the same Act, manufacturing industry of medicines shall obtain permission from the Minister of Health and Welfare for each item. In this case, the Minister of Health and Welfare may, if deemed necessary, request submission of documents concerning examination marks of manufactured items, clinical performance marks or test criteria and test method thereof. Under these provisions, the Minister of Health and Welfare, on December 16, 1964, enacted and promulgated No. 79 of the Public Notice of the Ministry of Health and Society, and applied for approval of the manufacture of new medicines, the Minister of Health and Welfare, without any justifiable reasons, shall make an application for approval of the manufacture of the above new medicines to the effect that the Plaintiff's disposal of medicines is more than 6 chemical basic experiment data such as determination of structure, efficacy and toxicity, basic test data of more than 2 general hospitals, and the method of administration of clinical drugs which are determined to be effective for more than 60 days in total and more than 60 days in total, and thus, the Pharmaceutical Affairs Act shall be divided into a more than the announcement.

Judges Song-man (Presiding Judge) Advice on Red Round