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The verification form must be saved as an editable Excel file as well as a PDF file under the name "Suchtmittel_Nachweis_2024_Ihr Betriebscode" and sent to suchtmittel@basg.gv.at in both formats. See also the instructions on the cover page. It is not necessary to send the printed form.

In accordance with the guidelines of the INCB, the total quantity of addictive substances present in the establishment must be reported as stock as at 31.12.. The quantity used for analysis during the year must be entered in the 'Loss' column. If a commercial package has been opened, the opened package must be booked out as a loss (consumption for analysis) in the "Preparations" tab. The remaining quantity must be entered on the "Substances" tab page as a multiple stock (and as a final stock). Subsequently, the quantities consumed are posted under "Loss" on the "Substances" tab page, thus reducing the closing stock.

Companies within the meaning of Section 2(1)(c) of the Regulations on Reblistering Operations or public pharmacies or institutional pharmacies (as contractors) act as vicarious agents of a public pharmacy or institutional pharmacy (as client) and may only reblister medicinal products on the basis of a written contract between the contractor and the client. This contract must be permanently available at the reblistering facility and its existence must be proven to the BASG upon request. In the case of prescription drugs, a prescription or narcotic prescription must be available in the pharmacy before the order for reblistering is placed.

According to § 11a Pharmacy Operations Regulations, the medication plan is the basis for the preparation of the blister ration. According to § 11a, Para. 4 of the Pharmacy Operations Regulations, it must be ensured that the patient receives the prescribed quantity by balancing the prescribed medications and those dispensed after reblistering. The commissioning pharmacy has the obligation to balance.

The monitoring of the patient-related drug quantity and associated prescriptions or narcotic prescriptions is therefore the responsibility of the commissioning pharmacy. In the event of loss (e.g. breakage) of medicinal products intended for reblistering, the reblistering company must report the incident to the commissioning pharmacy, which must decide on the provision of a replacement product to fulfill the order.

The commissioning pharmacy shall also decide on the whereabouts of any remaining stock of medicinal products that is not used for reblistering for the patient concerned.

Establishments pursuant to Section 2(1)(c) of the Regulations on Reblistering Operations must have a corresponding manufacturing license pursuant to Section 63(1) of the Austrian Medicines Act and, for the purpose of reblistering pursuant to Section 57(1)(3) of the Austrian Medicines Act, may only purchase the medicinal products required for this purpose from the manufacturer, distributor or wholesaler. In the case of reblistering operations, therefore, only the purchase of that specific number of medicinal products (on behalf of the pharmacy) is permissible for which an order or prescription for reblistering by the commissioning pharmacy exists. This company acts exclusively as a service provider of the public or institutional pharmacy. The dispensing of the medicinal specialties newly blistered by this company to the patient or to the nursing home must always be carried out by the pharmacy (direct dispensing is not permitted).

In the case of reblistering of narcotic drugs and psychotropic substances, the establishment must have a permit in accordance with § 2 Para. 1 Narcotic Drugs Ordinance or Psychotropic Substances Ordinance and make the corresponding reservations as well as the records. As soon as the narcotic drugs are purchased for the purpose of reblistering, the packages, as soon as they have been opened, are to be reported in the verification forms as dispensed for "reblistering" in the retail trade (reporting takes place at package level). The closing stock as of 31.12. at dose level must be reported in addition to the verification form (deblistered quantity as of 31.12.).

The complete detailed documentation at dose level and the allocability to the respective order or prescription, including any residual quantities (patient-related), must be available in the company and will be inspected as part of the monitoring of drug management. § Section 15 (4) of the Reblistering Ordinance provides for a numerical comparison of the drugs used for reblistering and the contents of the individual blisters of the facility.

Pharmacies may not supply medicinal products to medicinal product wholesalers or wholesalers may not purchase medicinal products from pharmacies (cf. Section 6 SMG, as well as Section 3 AMBO and Section 1 ABO). Exceptions to this are unavoidable returns (cf. § 33 AMBO).
A return from a pharmacy to a wholesaler is permissible if it is comprehensibly and fully documented that the returned goods originate from the wholesaler to whom the return is made or if a recall has been initiated by the wholesaler.

In all other cases, the BASG considers this to be an unauthorized supply by a pharmacy to a wholesaler, which can lead to administrative criminal charges being brought
It should also be noted:
As each business has a license that is limited in terms of substances and quantities and a complete traceability of the management is required, returns of narcotic drugs and psychotropic substances must be kept to an absolute minimum. As returned narcotics are to be included in the maximum quantity, returns may result in the maximum quantity being exceeded.
Returns must be documented. The documents must contain the following minimum information:

• Name and address of the returning party
• Date of return
• Medicinal specialty
• Quantity
• Reason for return (incorrect delivery/incorrect order/other discrepancy/quality defect/recall)
• Date of purchase of the medicinal product
• For chilled goods and narcotics - temperature records as an attachment
• Date and decision of the assessment of marketability (inclusion/disposal/rejection)

Each return must also be recorded as a withdrawal in the earmarks and therefore in the verification. Returns of complete retail packs must be reported in the statement as a reference in the “Returns from retail trade (for examination of disposal/re-integration)” column in the “Preparations” tab.

After checking the marketability, these can be allocated to the sales stock or sent for destruction. After physical disposal, the quantity must be reported in the “Disposal” column as part of the verification report. Reference is made to § 8 para. 1 no. 2 Narcotic Drugs Ordinance and § 8 para. 1 Psychotropics Ordinance.

The return of narcotics by pharmacies to wholesalers for the purpose of disposal must also be recorded in the records and therefore in the report. However, due to the fact that pharmacies and institutional pharmacies can dispose of narcotics free of charge via the laboratory of the Austrian Chamber of Pharmacists, there should be no need to return them to wholesalers.

Wholesalers are not permitted to supply (veterinary) medicinal products directly to doctors running in-house pharmacies or doctors in private practice, or to veterinarians without in-house pharmacies (see Section 6 SMG, Section 57 AMG and Section 43 TAMG). This means that returns to wholesalers by doctors running in-house pharmacies or registered doctors and veterinarians without a practice are also not permitted. The wholesaler can only act as a vicarious agent of an ordering pharmacy, which is authorized to dispense to in-house pharmacies or registered doctors and veterinarians. The following points must be observed:

1. The dispensing of medicinal products is carried out without exception in the name and under the responsibility of the pharmacy (§ 59 AMG).
2. it must be ensured by means of a contract that the orders/deliveries/returns received by the vicarious agent (wholesaler) are checked, monitored and, if necessary, objected to by the commissioning pharmacy at all times in order to ensure that the commissioning pharmacy is involved in accordance with the law.
3. in the case of returns, a returns form must exist, which must contain at least the following information:

• Name and address of the returning party
• Date of return
• Medicinal specialty
• Quantity
• Reason for return
• Date of purchase of the medicinal product
• Name and address of the ordering pharmacy
• For chilled goods and narcotics - temperature records as an attachment

Date and decision on the assessment of marketability (inclusion/disposal/rejection)
Returns processing requires the following documentation, which must be available when the goods are returned to the wholesaler (vicarious agent):

• Date of receipt of the return
• Check whether and when the goods or batch were actually delivered
• Specification of the reason for the return (incorrect delivery/incorrect order/other discrepancy/quality defect/recall)
• Complete temperature records covering the period from delivery to withdrawal of the return for the purpose of inspection and assessment
• Date and decision of the marketability assessment

The verification already takes place during the verification inspection or if a violation is detected in the course of the inspection. The maximum quantity permitted is calculated per calendar year from the opening stock plus additions (domestic purchases) plus imports. Returns also represent an addition and must therefore be taken into account. The calculated value may not exceed the maximum quantity value specified in the authorization.

If it becomes apparent that the maximum quantity will be exceeded, an application for an increase of the maximum quantity must be submitted to the BMSGPK in due time. The supplemental operating permit application must state the new total maximum quantity. The newly approved maximum quantity thus replaces the originally approved maximum quantity. The approved maximum quantities of those narcotic drugs for which no increase was applied for remain unaffected.

The statements regarding "direct supply" (on behalf and under the responsibility of the pharmacy) apply mutatis mutandis in the field of narcotic drugs. The BASG points out that according to § 12 SV, physicians and dentists, dentists and veterinarians are only allowed to obtain narcotic drugs for their home pharmacy and for their practice supplies from domestic public pharmacies.

If finished medicinal products containing addictive substances (end products / finished products) are manufactured in the company, the starting substances containing addictive substances (raw materials / bulk goods) must be reported in the detection form in the "Substances" tab.

In the case of starting materials, the molecular compound (e.g. the salt) must be indicated for both narcotic drugs and psychotropic substances. Conversion to the pure, anhydrous base by the facility is not required. It is possible to report bulk goods - in countable units - in the "Preparations" tab.

Official sampling as well as deliveries to external laboratories/scientific institutes/specialized institutions (which must have a confirmation pursuant to Section 6 (1) (2) of the SMG) must be reported as deliveries to the retail trade.

In principle, the international drug conventions of the UN distinguish between substances (those listed in the respective annexes of the drug conventions) and preparations (mixtures, regardless of their physical state, which contain at least one listed substance or are presented in dosage form). There are substances that are classified as narcotic drugs in Austria but are internationally subject to the Convention on Psychotropic Substances of 1971 (e.g. methylphenidate, buprenorphine), and there are substances that are classified as narcotic drugs in Austria but are not listed in the international narcotics conventions (e.g. tramadol, tapentadol). 

The INCB (International Narcotics Control Board) publishes in particular in the "Yellow List" for narcotics and the "Green List" for psychotropic substances the specifications for national authorities for reporting to the INCB. These include the conversion factors required for the determination of the base content, on the basis of which the base content is to be calculated from the respective compounds (esters, ethers or salts) ("pure anhydrous drug content"). Thus, the molecular compound contained in the preparation is to be indicated (e.g. oxycodone hydrochloride) and from this the base content is to be calculated with the respective conversion factor published by INCB. 

The procedure for calculating the base content of preparations, which has been agreed with INCB and BMSGPK, is as follows: 

• Active ingredient content of the contained molecular compound per unit x conversion factor according to Yellow / Green List = base content per unit
• base content per unit x number of units = base content per package size. 

A unit is e.g. a tablet, or in the case of liquids, the respective packaging unit e.g. a 2 mL ampoule. 

The master data on addictive substances published by BASG on its homepage already lists the respective preparations with the base content calculated as described above. In the verification form, the licensed establishments report the number of packages using the BASG master data set. When including new preparations according to form F_I313 in the BASG master data set, the calculation method described above must be used. 

As a manufacturer, you are requested to use the base content of the calculation method presented here as the nominal value and to inform your customers (in the case of exports) that, from the point of view of the BMSGPK/BASG, this would have to be used for import applications. 

In those cases where the strength is stated in the name or in the expert information of the medicinal product in relation to the pure, anhydrous base (although, for example, the active ingredient is contained as a salt), the authorities may use different calculation methods due to the lack of an internationally harmonized procedure. 

From the point of view of the BMSGPK/BASG, in the absence of international harmonization, the application of the base content according to the drug approval is also acceptable. A mandatory application of the conversion factors of the Yellow/Green List in these cases is refrained from, especially if the partner authority of the importing or exporting country uses the base content according to the drug approval or the application means additional administrative effort. 

Conclusion: It is therefore at the discretion of the manufacturing or importing company in Austria (in consultation with the marketing authorization holder or partner companies abroad) which calculation method is chosen in these cases to determine the base content. The BASG takes into account or checks the procedure chosen by the establishment when it is included in the BASG's master data on narcotic drugs. 

Subsequently, all Austrian companies should use the same base content according to the BASG master data for a specific preparation in the various procedures (verification, maximum quantities, import and export licenses).

This is a levy that has been included in the BASG fee schedule under item V.7 since 1.1.2016, and relates to the notification of evidence to the BASG by establishments licensed by the BMSGPK pursuant to Section 10 of the Narcotic Drugs Ordinance and Section 9 of the Psychotropic Drugs Ordinance.

• V.7 Notifications in the context of narcotic drug traffic as defined in Section 6 (1) no. 1 SMG per establishment according to the number of active substances notified (applications with submission date as of 1.1.2025)
• V.7.a: 0 active substances (processing fee for empty notification) 194 EURO
• V.7.b: 1 to 5 active substances: 655 EURO
• V.7.c: 6 to 20 active ingredients: 1.313 EURO
• V.7.d: More than 20 active ingredients: 2.622 EURO

The billing will be done according to the actually reported active substances (separated by narcotics / psychotropic substances) according to the detection reports.

§ Section 8 (2a) of the SV stipulates that delta-9-tetrahydrocannabinol isolated from cannabis extracts (I.1.a subject to the SV) must be labeled with the addition "cannabis extract" and shown separately from delta-9-tetrahydrocannabinol of synthetic origin. 

The reason for the separate documentation is that delta-9-tetrahydrocannabinol of synthetic origin is subject to the UN Psychotropic Convention, but cannabis, cannabis resin as well as the extracts, tinctures and other preparations made from them are covered by the UN Convention on Narcotic Drugs and thus have separate reporting and reporting obligations. 

However, the INCB provides for a change from 2024 to the effect that the content of delta-9-tetrahydrocannabinol is to be used to calculate the quantity of narcotic drugs in the case of extracts produced from cannabis (as well as delta-9-tetrahydrocannabinol isolated from it), tinctures and other preparations and allocated to the substance delta-9-tetrahydrocannabinol.

From 2024, delta-9-tetrahydrocannabinol will be reported in aggregated form, broken down into quantities of natural and synthetic origin, in accordance with the requirements of the Green List (UN Psychotropic Substances Convention). The separate documentation and reporting of delta-9-THC of natural origin (from cannabis extract) and delta-9-THC of synthetic origin (dronabinol) (see Section 8 para. 2a, Section 26 para. 1 no. 4a and Section 27 para. 1 no. 4a of the Narcotic Drugs Ordinance - SV) is still required.

In both cases, the pure quantity of active substance is now recorded. The BASG master data has been adjusted accordingly and must be used to calculate the quantities of narcotic drugs from 2024 (imports and exports, operating licenses, imports/maximum quantities, records).

In the course of the verification report, the loss quantities must be reported to the BASG, including processing losses, consumed quantities for analysis/research/development as well as shrinkage or unexplained losses. Documentation must be available at the plant for all losses.

In addition to the internal documentation, any identified shrinkage or unexplained losses must be reported immediately to the BASG by e-mail (suchtmittelverluste@basg.gv.at), stating the quantity, the medicinal product/substance and the facts of the case (the report card for drug losses must be used). The BASG will confirm receipt of the loss report upon request. The company must document the circumstances of the loss case, carry out a risk assessment/cause analysis and initiate corrective and preventive measures accordingly. A suspected theft must be reported to the police.

This measure, which was initiated in cooperation with the BMASGK and the police, serves to further reduce illegal drug trafficking and abuse.

The report must be submitted within 3 days from the date of discovery.

In the case of losses during transport, it must be agreed bilaterally which company (supplier/customer) will carry out the report.

A loss report to the lost property authority is not mandatory from the point of view of BASG.

The following data/records should be available in the company in the event of a loss that cannot be explained:

• Time of discovery of the loss
• Immediate measures taken
• Record of the loss incl. naming of the persons involved
• Associated documentation: flow of goods; picking order and record; weighing log / packing order; import permit / freight documents; delivery bill / invoice; customer takeover confirmation / narcotics receipt
• Root cause analysis and derived corrective and preventive actions.

If the lost quantity is found again at a later date, this must also be reported immediately.

Lost quantities arising in the course of production processes are not subject to reporting and will be checked in the course of the verification/inspection.

The obligation to designate a person in charge in the sense of Section 9 of the Administrative Penal Code results explicitly from Section 2 (4) no. 3 SV/PV. 

In principle, the person responsible for addictive substances is therefore responsible for compliance with the administrative provisions of the Addictive Substances Act under administrative criminal law (e.g. keeping records, etc.). 

In the event of a violation, the SMV may be held personally liable pursuant to Section 44(1)(1) of the SMG and any administrative criminal proceedings will be conducted against him/her (by name).

The SMV must be named by the company in the annual application for a permit to participate in drug use. He/she will be named in the corresponding permit according to §§ 2 SV or 2 PV. 

These permits are issued for the calendar year and are therefore always valid from 01.01. to 31.12. of the year granted. Since the name of the SMV is part of this permit, the designation is upheld according to the validity of the permit.

In case of changes in the person of the SMV, the BMGF must be informed immediately. In the event that a designated SMV leaves the company and no change in the authorization has been applied for, the authorization to participate in the traffic of narcotic drugs shall be revoked by the BMGF, as the prerequisite for the granting of the authorization has ceased to exist. 

Participation in the traffic of narcotic drugs without SMV is likely to have implications under administrative criminal law.

Yes. Section 2(4)(3) SV/PV provides for the designation of a responsible person within the meaning of Section 9 VStG. § Section 9 VStG regulates the responsibility under administrative criminal law "for compliance with administrative regulations by legal entities or registered partnerships" to the effect that, pursuant to para. 1 legcit., the persons appointed "to represent the company externally" (i.e. the statutory representative bodies) are in principle responsible for this. In turn, § 9 para. 2 leg.cit. opens up the possibility of transferring responsibility to these bodies by appointing "responsible representatives" as follows:

• insofar as the responsibility of such representatives is to extend to the entire company, they are to be appointed from among the statutory representative bodies themselves,
• insofar as it is to relate only to certain spatially or factually delimited areas of the company, "other persons" may also be considered.

By " other persons" - § 9 para. 2 last sentence VStG means employees or also authorized signatories (cf. Lewisch in Lewisch/Fister/Weilguni, VStG § 9 VStG, as of 1.7. 2013, rdb.at.) of the respective company in question. The appointed person must meet the requirements set out in Section 9(4) VStG and assumes responsibility under administrative criminal law in place of the statutory representative bodies of the company. Accordingly, a person who is not an employee of the company does not comply with the requirements of Sec. 9 (2) VStG.

In the case of smallest quantities of non-commercial molecular compounds to a substance which is subject to the Narcotic Drugs Ordinance or Psychotropic Substances Ordinance (in practice these are reference standards of related substances such as impurities or degradation products), the base content is set at 100% due to the difficulty of determining the base content and the low relevance. 

The exact name of the narcotic drug or psychotropic substance must be indicated on the import or export application forms. In case of an import application, it is recommended to consult with the exporter regarding the designation on the license before applying. In the declaration, the quantity is to be reported as base in the tab "Substances", without specifying the exact designation of these rare compounds.

Under the law on narcotic drugs, a new operating license is applied for annually from the BMASGK, specifying the narcotic drugs required. The authorization for wholesalers under drug law lists drugs with special requirements under item 3, including narcotic drugs and psychotropic substances. 

This applies - under pharmaceutical law - to the placing on the market, i.e. ownership and possession of narcotic drugs must be shown in the operating license under pharmaceutical law in the case of pharmaceutical wholesalers. 

Changes to the addictive drug portfolio are subject to approval as a significant change (scope of activity) pursuant to Section 65 (1) AMG (extension: application for change pursuant to Section 65 (1) AMG; reduction: partial waiver pursuant to Section 66b AMG (to be submitted informally)). 

The storage of medicinal products containing addictive substances may only take place in premises approved under medicinal product law (cf. zoning plans § 11 Para. 2 AMBO 2009).

In the event of a relocation in the case of drugs containing addictive substances, it must be noted that the goods may only be stored/marketed (or manufactured/controlled) at locations with valid licenses under trade law and drug and pharmaceutical law. It must be ensured that the corresponding site-specific permits are available at both sites for the period of the complete relocation. 

The addictive drugs license is only issued after the site-related business license and the drug license have been obtained. 

Therefore, in the event of a transfer of narcotic drugs for the purpose of possession of narcotic drugs, the application for a new business location pursuant to Section 63 AMG is required (instead of an application for change pursuant to Section 65 AMG) in order to ensure that narcotic drugs are stored at licensed locations at all times. 

Under narcotics law, the transfer must be documented by determining the stock on departure, as well as the secured transport and storage at the new location. If the transfer does not take place selectively, the documentation of each storage movement must be based on the respective location.

Holders of a confirmation pursuant to Section 6 of the SMG and all persons authorized to handle narcotic substances pursuant to Section 6 of the SMG are obliged to keep records containing all information pursuant to Sections 8 and 9 of the SMG and Section 8 of the SMG, subject to additional requirements imposed by the supervisory authority. Security measures pursuant to Section 9 of the SMG must be taken.

The change of possession between authorized participants in narcotics traffic usually requires transport. In the case of a commissioned transporter, the latter acts as a vicarious agent and is to be assigned to either the supplier's or the customer's area of responsibility in legal narcotics traffic. The transfer of responsibility under narcotics law from the supplying company to the authorized recipient takes place accordingly at the time of the transfer of risk (ex works/free domicile) and must be documented accordingly.

In the case of deliveries over the turn of the year, the goods are to be attributed either to the delivering company or to the purchaser according to the time of the transfer of risk. There can only be one time of transfer of risk per transport operation.

In principle, no authorization is required for pure (commercial) transport between participants authorized to traffic in narcotics (and for the associated transshipment) (postal services, parcel services, pure logistics service providers). This also applies to transhipment in "hubs". Prerequisite: the shipments are not opened or manipulated. This means that narcotics in transit must be clearly marked (closed packaging/package, sender, recipient) as transshipped goods ("package on the move"), otherwise storage of narcotics (subject to authorization) is applicable.

The focus of the legal requirements for the transport of narcotic drugs is the complete traceability of the distribution chain through appropriate documentation coupled with safety precautions in order to prevent diversion and consequently misuse of the narcotic drugs. The documentation in accordance with addictive substances legislation must include all processes relating to the handling of addictive substances.

As soon as the consignment has reached the recipient, the goods have lost the status of "package in transit" and are the responsibility of the recipient. The receipt of narcotic drugs must be processed by the company immediately (without unjustifiable delay). 

Provided that the storage is secured and the documentation is complete, a maximum period of 3 working days is accepted until the incoming goods inspection is completed (and thus the purchase is recorded in the reservations). 

Even in the case of goods to be returned, they are considered as purchased; the return constitutes a delivery. Refusal to accept the shipment (goods do not leave the transport route and remain with the carrier) does not constitute a purchase of the goods.

Individual cases of incorrect deliveries (e.g. wrong addressee, unordered/unwanted goods which are immediately returned/forwarded) do not have to be recorded as a purchase (reservations/references), subject to bilateral agreement with the trading partner.

The disposal of addictive substances must be documented. Narcotics as waste must be disposed of in accordance with the provisions of waste management law, in practice by thermal recycling. 

The disposal must be organized by the company in such a way that the addictive substances to be disposed of are secured against unauthorized removal until actual destruction, thus preventing diversion and misuse. 

Minimum requirements for disposal:

• Delivery of the addictive substances to be disposed of to a body legitimized in accordance with the SMG, which offers the disposal of addictive substances (with confirmation of acceptance) as a service, or
• Commissioning of a disposal company to collect and drive directly to a waste incineration plant to destroy the addictive substances, with sealing of the vehicle or accompanied by the SMV / addictive substances officer, or
• Commissioning of a disposal company for the collection and destruction of the addictive substances, provided that these are handed over in disposal containers that are not accessible to opening / subsequent removal. 

The process of transferring the addictive substances into the containers must be documented accordingly in the company. The container-specific documentation must be retained. 

In general, narcotic drugs to be destroyed should be disposed of by the companies by the end of the year, as the INCB also takes into account the quantities stored in Austria as of 31.12. for the determination of the annual import quota. 

Residual quantities / residues of small quantities of narcotics in the laboratory area can be disposed of properly documented via the chemical waste.

Example: A wholesaler who does not have a licence under narcotics law orders a narcotic drug. The goods would be delivered directly to a public pharmacy or to an authorised logistics service provider, and the invoice would be sent to the unauthorised wholesaler. 

The ordering wholesaler would never be in physical possession of the goods.

When is a participant in the narcotics trade subject to authorisation?

Answer: Participants in the legal drug trade require a licence if they

• physically handle narcotics (e.g. store, process) and/or
• handle imports and exports of narcotics in their own name (regardless of whether the narcotics are held at the same location or stored by a logistics service provider at another (authorised) business premises).