3 Key Differences Between SPL & SPM

SPL and SPM each play a vital role in making drug information easy for health providers and patients to understand. But what are they, and how are they different?

Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard for formatting product and drug information, enabling the exchange of data in a consistent and machine-readable format, XML. Having a single format enables automated data processing and faster retrieval of information. This makes it easier for consumers and healthcare providers to search for relevant and concise drug information.

The United States implemented SPL in 2005, initially only for products regulated by the Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER). In 2009, the FDA expanded the requirement to include all over-the-counter (OTC) and Veterinary medicines, as well as requiring that all companies who produce OTCs, Pharmaceuticals, Biologics, and Veterinary medicines submit their registration and listing files in SPL format. The SPL documents contain the Content of Labeling as well as data about the products. Some of the information contained in the file includes ingredients, indications, contraindications, dosage, administration, and safety.

A Structured Product Monograph (SPM) is Health Canada’s implementation of SPL, which it announced in 2019. SPMs contain thorough information about a drug product, such as its chemistry, pharmacology, toxicology, and details about clinical trials.

Like the FDA’s implementation, SPM contains the Content of Labeling for the product as well as data about the product, coded in order to make it easier for systems to read and exchange information.

While SPL and SPM are both based on HL7’s standard product model, there are three key differences:

Scope
Codes
Languages

A Closer Look at What Makes SPL & SPM Different

1. Scope

SPLs and SPMs provide detailed information about medical products, such as their composition, indications, usage and dosage, adverse reactions, and other important safety information. They are used for regulatory compliance and to provide healthcare providers with the most up-to-date, accurate, and comprehensive information about the products they prescribe. SPLs contain a plethora of product data elements like:

Product name
Route of administration
Active, inactive, and adjuvant ingredients
Drug Enforcement Administration (DEA) schedule
Product type
Dosage form
Strength of active ingredient
Basis of strength
Content of labeling text sections (e.g., 12.1 Mechanism of Action)
Application number
Distributor’s name
Production characteristics like color, shape, and size (for example)
Information on packaging
Marketing information like the category, status, start and end date
Representative samples of cartons or containers

Meanwhile, the detailed information provided in SPMs differs from what’s included in SPL because Health Canada has its own regulatory requirements to follow:

Product name
Therapeutic or pharmacologic classification
Actions and/or clinical pharmacology
Indications
Contraindications
Dosage and administration
Symptoms and treatment of overdosage
Dosage forms
Warnings
Precautions
Adverse reactions
Drug interactions
Effects on laboratory tests
Storage and stability
Special handling instructions
Pharmaceutical information
Information on clinical trials
Microbiology
Toxicology
Information for the patient
Dates of initial approval
When applicable, the date of the last revision

Despite their differences in product information, SPLs and SPMs aim to help doctors, pharmacists, and patients make informed decisions. In addition, FDA requires all registration and listing files (e.g. Establishment Registration, NDC/NHRIC Labeler Code Request) to be submitted in SPL format. Conversely, the initial requirements for Health Canada SPM submissions only include product monographs.

2. Codes

In the U.S., all drug products are assigned a National Drug Code (NDC) that is unique for the product and labeler combination. The first 2 segments of the NDC Code uniquely identify the drug product and all of its characteristics while the third segment identifies distinct packaging configurations in which the product is marketed.

Health Canada drug label codes are unique codes used to identify prescription and over-the-counter drugs in Canada. These codes are assigned to products by Health Canada and used in the Drug Identification Number (DIN) system. The codes are typically eight characters long and consist of a series of numbers, letters, and symbols.

3. Languages

In the U.S., SPL is an English-only system. But Canada’s Food and Drugs Act and Regulations state that all product labels, including monographs, must be in both of its official languages: English and French. What this means in terms of SPM files is that not only does the Content of Labeling need to be submitted in both English and French, but all of the descriptions of the codes used to define the product must be submitted in both English and French.

SPL and SPM also differ in their requirements for plain language. Since 2014, Health Canada has required plain language elements in their product monographs to make information easier to understand for all Canadians. To support this, Health Canada provides tools to evaluate text for plain language at grade 6 to 8 reading level. By providing this material in both English and French, in plain language, and on the Internet, Canada can reach as many of its citizens with as much accurate information about health products as possible.

Conclusion

Understanding the differences between SPL and SPM can help your pharma company comply with the regulatory authorities, which is necessary for getting your drugs to market. The product information, codes, and languages are unique to each standard, so keep them in mind as you create these documents for your products.

SPL Portal by Intagras is a pharmaceutical labeling submission tool that can create and submit SPL and SPM files with ease. Contact us to get started for free.

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