Article 1.　This Law aims to exercise necessary control concerning import, possession, manufacture, transfer, receipt and use of awakening drug for the sake of the prevention of injuries to health and hygiene through the abuse thereof.

Article 2.　The meaning of terms as used in this Law shall be defined in the following items:

Article 3.　The designation of awakening drug manufacture shall be exercised by the Minister of Welfare with respect to each manufactory as to any one recognized by him as proper from among the qualified persons mentioned in the following items;with respect to designation of awakening drug administering institution or awakening drug research worker, as to any one recognized as proper by the Governor of To, Do, Fu or prefecture of the location with respect to each hospital, clinic or research institute from among the qualified persons on institutions mentioned in the following items:

2　The standard of designation concerning awakening drug administering institution and awakening drug research worker shall be fixed by Ministry of Welfare Ordinance.

Article 4.　Any one who wants to apply for the designation as awakening drug manufacturer shall submit application to the Minister of Welfare through the governor or To, Do, Fu or prefecture of the location of the manufactory with respect to each manufactory.

2　Any one who wants to apply for the designation as awakening drug administering institution or awakening drug research worker shall submit application, with respect to each hospital, clinic or research institute, to the governor of To, Do, Fu or prefecture of the location thereof.

Article 5.　In case the designation with respect to awakening drug manufacturer, awakening drug administering institution or awakening drug research worker has been exercised, the Minister of Welfare shall, with respect to awakening drug manufacturer concerned;the governor of To, Do, Fu or prefecture shall, with respect to the establisher of awakening drug administering institution concerned or awakening drug research worker concerned;issue respectively designation certificate.

2　The issue of the designation certificate for awakening drug manufacturer shall be exercised through the governor of To, Do, Fu or prefecture of the location of the manufactory.

3　The designation certificate shall not be transferred or loaned.

Article 6.　The effective term of designation for awakening drug manufacturer, awakening drug administering institution or awakening drug research worker shall be from the date of designation to December 31 of the next year.

Article 7.　As the same with the cases where the effective term of designation has elapsed with respect to awakening drug manufacturer, awakening drug administering institution or awakening drug research worker or where the designation thereof has been cancelled, the designation shall be ineffective when the cause under Article 9 (Notification of Abolition, etc. of Business) has arisen.

Article 8.　In case awakening drug manufacturer, establisher of awakening drug administering institution, manager (meaning the manager of hospital or clinic concerned under the provision of the Medical Service Law (Law No.205 of 1948);hereinafter the same) of awakening drug administering institution, physician engaged in medical treatment in the awakening drug administering institution or awakening drug research worker has violated the provision of this Law or the disposition thereunder, or in case the qualification mentioned in item (3) of Article 3 paragraph 1 (Condition of Designation) has lapsed with respect to awakening drug research worker, the Minister of Welfare may, with respect to the awakening drug manufacturer;the governor of To, Do, Fu or prefecture may, with respect to the awakening drug administering institution or the awakening drug research worker, cancel the designation respectively.

2　In case the Minister of Welfare or the governor of To, Do, Fu or prefecture intends to make the disposition under the preceding paragraph, he shall notify, not less than two weeks in advance to the date the awakening drug manufacturer, establisher of awakening drug administering institution or awakening drug research worker concerned who is to be-dealt with the disposition, of the reason for the disposition as well as the date and place of the hearing, and hold a hearing requesting the attendance of the person concerned or his representative.

3　At the hearing, the person or his representative who is to undergo the disposition may give explanation on behalf of himself or the represented person and produce profitable evidence.

4　In case the person who is to be dealt with the disposition concerned or his representative failed to attend a public hearing without justifiable reason on the day of hearing, the Minister of Welfare or the governor of To, Do, Fu or prefecture may make the disposition under paragraph 1 without holding a hearing.

Article 9.　In case awakening drug manufacturer comes under any one of the following items, he shall notify to that effect to the Minister of Welfare within fifteen days from the day when the cause thereunder has arisen through the governor of To, Do, Fu or prefecture of the location of the manufactory attaching the designation certificate:

2　The establisher of awakening drug administering institution shall, in case he comes under any one of the following items, notify, within fifteen days from the day when the cause has arisen, to that effect, attaching designation certificate, to the governor of To, Do, Fu or prefecture of the location of the hospital or clinic:

3　In case awakening drug research worker abolished the research work which needs awakening drug in the research institute, he shall notify, within fifteen days from the day of the abolition, to that effect to the governor of To, Do, Fu or prefecture of the location of the research institute attaching the designation certificate.

4　The notification under the preceding three paragraphs shall, in case of death of awakening drug manufacturer, establisher of awakening drug administering institution or awakening drug research worker, be conducted by the heir;in case of dissolution, by the liquidator or the legal person which may continue after amalgamation or set up by amalgamation.

Article 10.　In case the designation of awakening drug manufacturer, awakening drug administering institution or awakening drug research worker has become ineffective, except for the case under the preceding Article, designation certificate shall be returned respectively within fifteen days after the lapse of the designation, with respect to former awakening drug manufacturer, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of the manufactory thereof;with respect to former establisher of awakening drug administering institution or former awakening drug research worker, to the governor of To, Do, Fu or prefecture of the location of the hospital, clinic or research institute thereof.

2　In case awakening drug manufacturer received the disposition of suspention of business under the provision of Article 46 paragraph 3 (Cancellation of License and Suspension of Business) of of the Pharmaceutical Affairs Law or the establisher of awakening drug administering institution received the order of suspension under the provision of Article 29 (Cancellation of Permission for Establishment and Order of Suspension) of the Medical Service Law, he shall present respectively the designation certificate within fifteen days from the day or receiving the disposition, with respect to awakening drug manufacturer, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of the manufactory thereof;with respect to the establisher of awakening drug administering institution, to the governor of To, Do, Fu or prefecture of the location of the hospital or clinic thereof.

3　In the case of the preceding paragraph, the Minister of Welfare or the governor of To, Do, Fu or prefecture shall, immediately after the lapse of the term of suspension of business or the term of closing, return the designation certificate, entering the purport of the disposition, to awakening drug manufacturer or establisher of awakening drug administering institution.

Article 11.　In case designation certificate has been injured or lost awakening drug manufactuer may apply for the reissue of designation certificate to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of the manufactory thereof;establisher of awakening drug administering institution or awakening drug research worker, to the governor of To, Do, Fu or prefecture of the location of the hospital, clinic or research institute thereof.

2　In case any one has found the lost designation certificate after applying for the reissue, he shall return respectively the former designation certificate within fifteen days, in case of awakening drug manufacturer, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of the manufactory thereof;in case of establisher of awakening drug administering institution or awakening drug research worker, to the governor of To, Do, Fu or prefecture of the location of the hospital, clinic or research institute thereof.

Article 12.　Awakening drug manufacturer shall, in case he changed his name (in case of legal person, the title) or address or title of manufactory, notify to that effect, attaching designation certificate, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of the manufactory within fifteen days.

2　Establisher of awakening drug administering institution shall, in case he changed the title of the awakening drug administering institution, notify to that effect, attaching designation certificate, to the governor of To, Do, Fu or prefecture of the location of the hospital, or clinic thereof within fifteen days.

3　Awakening drug research worker shall, in case he has changed the name or address or the title of the research institute, notify to that effect, attaching designation certificate, to the governor of To, Do, Fu or prefecture, within fifteen days, of the location of the research institute thereof.

4　In case of the preceding three paragraphs, the Minister of Welfare or the governor of To, Do, Fu or prefecture shall immediately amend the designation certificate and return the same.

Article 13.　No one shall import awakening drug.

Article 14.　Any one other than awakening drug manufacturer, establisher and manager of awakening drug administering institution, physician engaged in medical treatment in awakening drug administering institution, awakening drug research worker as well as the person who has received the delivery for administering from the physician engaged in medical treatment in the awakening drug administering institution, shall not possess awakening drug.

2　The provision of the preceding paragraph shall not apply in the case of any one who comes under any one of the following items:

Article 15.　Except for the case awakening drug manufacturer manufactures for the purpose of his business, no one shall manufacture awakening drug.

2　The Minister of Welfare may fix every year the manufacture quantity of awakening drug manufacturer for each term of January to March, April to June, July to September and October to December.

3　Awakening drug manufacturer shall not manufacture awakening drug in excess of the quantity fixed by the Minister of Welfare under the provision of the preceding paragraph.

Article 16.　The business concerning receipt of awakening drug administered in awakening durg administering institution and the management thereof in the awakening drug administering institution shall be conducted by manager of the administering institution concerned.

2　Establisher of awakening drug administering institution shall make the manager of the administering institution concerned conduct the business concerning receipt of awakening drug and the management of the awakening drug received.

Article 17.　Awakening drug manufacturer shall not transfer the awakening drug he manufactured to any one other than awakening drug administering institution and awakening drug research worker.

2　Awakening drug administering institution or awakening drug research worker shall not receive awakening drug from any one other than awakening drug manufacturer.

3　Except for the cases of the preceding two paragraphs as well as in case physician engaged in medical treatment in awakening drug administering institution delivers awakening drug for administering thereof, no one shall transfer or receive awakening drug.

4　The provision of the preceding paragraph shall not apply in case of transfer or receipt of awakening drug with respect to the enforcement of official business exercised in accordance with laws and ordinances.

Article 18.　In case of transfer or receipt of awakening drug, (excluding the case where the physician engaged in medical treatment in awakening drug administering institution delivers awakening drug for administering) the transferrer shall deliver transfer form issued by To, Do, Fu or prefecture;the receiver shall deliver receipt form issued by To, Do, Fu or prefecture;to other party entering all necessary informations and placing his seal thereupon.

2　Any one who has received transfer form or receipt form in accordance with the provision of the preceding paragraph shall keep it for the period of two years from the day of transfer or receipt.

3　Transfer form and receipt form shall not be transfer red to other person except for the case under the provision of paragraph 1.

Article 19.　No one shall use awakening drug except for the cases coming under following items:

Article 20.　Physician engaged in medical treatment in awakening drug administering institution shall not administer or deliver for administering awakening drug which is not managed by manager of awakening drug administering institution in which he is engaged in medical treatment.

2　Physician mentioned in the preceding paragraph shall not administer or deliver for administering awakening drug except for the purpose of medical treatment for other person.

3　Physician mentioned in paragraph 1 shall not administer or deliver for administering awakening drug to an addict of awakening drug for relieving his addiction or for treatment thereof.

4　In cases where the physician mentioned in paragraph 1 delivers awakening drug for administering, a note with address, name, age of any one delivered entered therein, administering method and term of administering with the signature of the physician concerned shall be delivered at the same time.

5　The awakening drug research worker shall not administer awakening drug to other person for research work.

Article 21.　Awakening drug manufacturer shall put the awakening drug he manufactured into a container with the seal issued by the Government as fixed by Ministry of Welfare Ordinance.

2　Awakening drug manufacturer, awakening drug administering institution and awakening drug research worker shall not transfer or receive awakening drug unless it has been sealed under the provision of the preceding paragraph.

3　In case awakening drug is transferred or received with respect to the execution of official business under laws and ordinances, the provision of the preceding paragraph shall not apply.

Article 22.　Awakening drug manufacturer, manager of awakening drug administering institution or awakening drug research worker shall take custody of awakening drug he possesses or manages in the safe place with lock in his factory, hospital, clinic or research institute.

Article 23.　In case awakening drug possessed or managed by awakening drug manufacturer, manager of awakening drug administering institution or awakening drug research worker has been lost, stolen or the whereabouts has been unknown, he shall notify without delay the name, quantity and other necessary matters to make clear the situation of the accident, with respect to awakening drug manufacturer, to the Minister of Welfare through the Governor of To, Do, Fu or prefecture of the location of his manufactory;with respect to manager of awakening drug administering institution or awakening drug research worker, to the Governor of To, Do, Fu or prefecture of the location of hospital, clinic or research institute.

Article 24.　When the designation of awakening drug manufacturer, awakening drug administering institution or awakening drug research worker has lapsed (in cases where the application of designation under the following Article has been made, the time when the disposition of denial has been made), former awakening drug manufacturer, former establisher awakening drug administering institution or former awakening drug research worker shall respectively report the name and quantity of awakening drug which has been owned at the time of the lapse of designation within fifteen days after the day of the lapse of designation (in cases where the application of designation under the following Article has been made, the day when the disposition of denial has been made;hereinafter the same in this Article), with respect to awakening drug manufacturer, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of his manufactory;with respect to awakening drug administering institution or awakening drug research worker, to the governor of To, Do, Fu or prefecture of the location of hospital, clinic or research institute.

2　In the case of the preceding paragraph, former awakening drug manufacturer, former establisher of awakening drug administering institution or former awakening drug research worker shall transfer, within thirty days after the day of the lapse of designation, the awakening drug he owns to present awakening drug manufacturer, present awakening drug administering institution or present awakening drug research worker, and name and quantity of awakening drug as well as name (title in case of legal person) and address of receiver shall be respectively reported, with respect to awakening drug manufacturer, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of his manufactory;with respect to awakening drug administering institution or awakening drug research worker, to the governor of To, Do, Fu or prefecture of the location of his hospital, clinic or research institute.

3　In case he failed to transfer the awakening drug concerned within the time limit of the preceding paragraph, former awakening drug manufacturer, former establisher of awakening drug administering institution or former awakening drug research worker shall immediately demand the attendance of the officer concerned and shall dispose of the awakening drug in accordance with his direction.

4　The report under the provision of paragraph 1 as well as the transfer and report under the provision of paragraph 2 and the disposition under the preceding paragraph shall be, in case former awakening drug manufacturer, former establisher of awakening drug administering institution or former awakening drug research worker has been dead, conducted by the heir;and in case of dissolution, by the liquidator or legal person continuing to exist after amalgamation or set up by amalgamation.

5　In the case of the preceding three paragraphs, with respect to former awakening drug manufacturer, former establisher of awakening drug administering institution, former awakening drug research worker as well as the heir, liquidator or legal person which continue to exist after amalgamation or set up by amalgamation, the provision of Article 14 paragraph 1 (Prohibition of Possession) shall not apply during the period from the day of the lapse of designation to the transfer or disposition under the provision of the same paragraph, and with respect to the business assistant thereof, the provision of item (1) of paragraph 2 (Exception to Prohibition of Possession) of the same Article;with respect to any one engaged in the service of post or transportation, the provision of item (2) of the same paragraph;shall apply mutatis mutandis.

6　In the case of paragraph 2 and paragraph 4, provisions of Article 17 (Restriction and Prohibition of Transfer and Receipt) and Article 21 paragraph 2 (Prohibition of Transfer and Receipt of Awakening Drug which has not been Enclosed with Seal) shall not apply.

Article 25.　In case former awakening drug manufacturer, former establisher of awakening drug administering institution or former awakening drug research worker applied anew for designation as awakening drug manufacturer, awakening drug administering institution or awakening drug research worker before the lapse of the effective term of designation provided for in Article 6 (Effective Term of Designation) or within thirty days after the lapse of the term, the provision of Article 14 paragraph 1 (Prohibition of Possession) and the provision of the preceding Article shall not apply, with respect to the afore-mentioned persons and former manager of awakening drug administering institution concerned, until the decision of permission or not of the Minister of Welfare or the governor of To, Do, Fu or prefecture concerning the abovementioned application is made.

Article 26.　The Minister of Welfare or the governor of To, Do, Fu or prefecture may make necessary disposition to attain the purpose of this Law concerning awakening drug imported, possessed, manufactured, transferred or delivered for administering in violation of the provision of this Law.

2　Governor of To, Do, Fu or prefecture shall, in case he has exercised the disposition provided for in the preceding paragraph, report the result of the disposition to the Minister of Welfare.

Article 27.　The Minister of Welfare may make necessary disposition to attain the purpose of this Law, upon consultation with the Minister of Finance, concerning the awakening drug reverted to the State Treasury in accordance with the provisions of laws and ordinances.

Article 28.　Awakening drug manufacturer, manager of awakening drug administering institution and awakening drug research worker shall respectively prepare book for each of his manufactory, hospital, clinic or research institute and enter following matters:

2　Any one under the preceding paragraph shall keep the book under the same paragraph during the period of two years after the last entry.

Article 29.　Awakening drug manufacturer shall report to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of his manufactory on the following matters by the tenth of the following month:

Article 30.　Manager of awakening drug administering institution or awakening drug research worker shall report every year by December 15 to the governor of To, Do, Fu or prefecture of the location of the hospital, clinic or research institute thereof the name and quantity of awakening drug received, administered, delivered for administering or used for research from the day of receiving designation (December 1 of the preceding year in case of the next year after the receipt of designation) to November 30.

Article 31.　The Minister of Welfare or the governor of To, Do, Fu or prefecture may, in case he deems it necessary for the control of awakening drug, demand necessary report with respect to awakening drug manufacturer, establisher or manager of awakening drug administering institution or awakening drug research worker.

Article 32.　The Minister of Welfare or the Governor of To, Do, Fu or prefecture may, in case it is necessary for the control of awakening drug, make officer concerned enter the premises and examine book and other materials of manufactory of awakening drug manufacturer, hospital or clinic as awakening drug administering institution or research institute of awakening drug research worker, take away the necessary minimum for examination of awakening drug or material suspected of being awakening drug or may question with respect to awakening drug manufacturer, establisher or manager of awakening drug administering institution, physician engaged in medical treatment in awakening drug administering institution awakening drug research worker or others concerned.

2　The provision of the preceding paragraph shall not be interpreted as having been allowed for the purpose of criminal research.

Article 33.　The official right of the officer concerned under Article 24 paragraph 3 (Disposition of Awakening Drug in Possession at the Lapse of Designation) and paragraph 1 of the preceding Article shall be exercised by the inspector of drugs under Article 50 (Appointment of Inspector of Drugs) of the Pharmaceutical Affairs Law.

2　The inspector of drugs shall, in case he attends at the disposition of awakening drug under the provision of Article 24 paragraph 3 or enter, examine, take away or question under paragraph 1 of the preceding Article, take his identification certificate with him and present it on demand of the person concerned.

Article 34.　The governor of To, Do, Fu or prefecture shall, in case he considers the disposition under Article 8 paragraph 1 (Cancellation of Designation) necessary with respect to awakening drug manufacturer, present his opinion to the Minister of Welfare to that effect.

Article 35.　With respect to the hospital or clinic established by the State, the Minister of Welfare may exercise the designation of awakening drug administering institution regardless of the part of the provision concerning the authorities having the right of designation in Article 3 paragraph 1 (Condition of Designation) and the provision of Article 4 paragraph 2 (Procedure of Application for Designation) upon consultation with the competent Minister.

2　The governor of To, Do, Fu or prefecture may, with respect to hospital or clinic established by To, Do, Fu or prefecture, exercise the designation of awakening drug administering institution regardless of the provision of Article 4 paragraph 2.

Article 36.　With respect to awakening drug administering institution established by the State or by local public body, notification, return of designation certificate and report mentioned in the following items shall be exercised by manager (in cases where there is no manager, officer designated by the establisher) of administering institution concerned, with respect to awakening drug administering institution established by the State, to the Minister of Welfare through the governor of To, Do, Fu or prefecture of the location of the hospital or clinic;and with respect to awakening drug administering institution established by local public body, the above shall be exercised to the governor of To, Do, Fu or prefecture of the location of the hospital or clinic:

2　With respect to the awakening drug administering institution established by the State or local public body, transfer or disposition of awakening drug under the provision of Article 24 paragraph 2 (Transfer of the Awakening Drug Owned at the Lapse of Designation and the Report thereof) or paragraph 3 (Disposition of Awakening Drug Owned at the Lapse of Designation) shall be exercised by manager (in cases where there is no manager, officer designated by the establisher) of the administering institution concerned.

3　In the case of the preceding paragraph, the provision of Article 24 paragraph 5 (Exception to Prohibition of Possession) and paragraph 6 (Exception to Restriction and Prohibition of Transfer and Receipt) shall apply mutatis mutandis.

Article 37.　Except for the case provided for by this Law, necessary special instance with respect to the application of the provision of this Law to the awakening drug administering institution established by the State shall be fixed by Ministry of Welfare Ordinance.

Article 38.　Any one who comes under any one of the following items shall pay the amount of fee fixed in each item concerned respectively:

2　With respect to the fee of item (1) of preceding paragraph and the fee paid by any one who applies for reissue of designation certificate of awakening drug manufacturer in item (4), one half of the amount shall be the revenue of the State Treasury, and the balance shall be that of To, Do, Fu or prefecture, and the whole amount of the other fee shall be the revenue of To, Do, Fu or prefecture.

Article 39.　Any one who needs the blank form of transfer form or receipt from provided for under Article 18 (Transfer Form and Receipt Form) shall pay respectively to To, Do, Fu or prefecture two yen as the price per piece and any one who needs the seal under Article 21 paragraph 1 (Enclosing with Seal of Manufactured Awakening Drug) shall pay respectively 20 sen as the price per piece to the State Treasury.

Article 40.　With respect to notification, return or presentation of designation certificate or report to be submitted to the Minister of Welfare through the governor of To, Do, Fu or prefecture under the provision of this Law, in case the notification, designation certificate or report has been presented to the governor of To, Do, Fu or prefecture within the time-limit fixed under the provision concerned, it shall be regarded as having been exercised within the fixed time-limit.

Article 41.　Any one who comes under any of the following items shall be liable to a penal servitude not exceeding three years or a fine not exceeding 50,000 Yen:

2　The punishment of paragraph 1 may be inflicted jointly according to circumstances.

3　Attempted offence of paragraph 1 item (1) and items (3) to (6) inclusive shall be punished.

Article 42.　Any one who comes under any of the following items shall be liable to a penal servitude not exceeding one year or a fine not exceeding 30,000 yen:

2　Punishment of the preceding paragraph may be inflicted jointly according to circumstances.

Article 43.　Any one (the representative in case of legal person) who comes under any of the following items shall be liable to a non-penal fine not exceeding 10,000 yen:

Article 44.　In case the act of violation (including the case of attempted offence) under the provision of Article 17 paragraph 2 (Prohibition of Receipt from Any One other than Awakening Drug Manufacturer), Article 18 paragraph 1 (Delivery of Transfer Form and Receipt Form) or paragraph 3 (Prohibition of Transfer of Transfer Form and Receipt Form), or violation under the provision of Article 21 paragraph 2 (Prohibition of Transfer and Receipt of Awakening Drug without Enclosing with Seal) has been committed with respect to awakening drug administering institution (except for the case where the establisher is the State or local public body), not only the establisher of the institution concerned but also the manager thereof shall be liable to the punishment of Article 41, or Article 42;provided that this provision shall not apply in cases where the manager concerned has not known the act of violation.

2　In case there has been any act of violation of provision mentioned in Article 5 paragraph 3 (Prohibition of Transfer and Loan of Designation Certification), Article 18 (Delivery, Preservation and Prohibition of Transfer of Transfer Form and Receipt Form) or Article 21 paragraph 2 (Prohibition of Transfer and Receipt of Awakening Drug without Enclosing with Seal) with respect to awakening drug administering institution established by the State or local public body, the manager of the administering institution concerned shall be liable to the penalty of Article 42 or nonpenal fine of the preceding Article.

Article 45.　In cases where any representative of a legal person, or proxy, employee or other workers of a legal person or of a natural person commits the violation under Article 41 or 42 for the business of the legal person or the natural person, not only the offender shall be punished, but also the legal person or the natural person concerned shall be liable to a fine under each Article;provided that this shall not apply to the legal person or the natural person if it has been proved that due care and supervision have been exercised over the business in order to prevent the aforesaid violation committed by the proxy, employee or other workers.